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PubMed Journals Articles About "A Trial In Healthy Female Subjects To Compare The Pharmacokinetics Of Ethinyl Estradiol Of NuvaRing®, A Contraceptive Patch (EVRA(TM)) And An Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)" - Page: 2 RSS

16:28 EDT 23rd March 2019 | BioPortfolio

A Trial In Healthy Female Subjects To Compare The Pharmacokinetics Of Ethinyl Estradiol Of NuvaRing®, A Contraceptive Patch (EVRA(TM)) And An Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED) PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest A Trial In Healthy Female Subjects To Compare The Pharmacokinetics Of Ethinyl Estradiol Of NuvaRing®, A Contraceptive Patch (EVRA(TM)) And An Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED) articles that have been published worldwide.

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Showing "Trial Healthy Female Subjects Compare Pharmacokinetics Ethinyl Estradiol" PubMed Articles 26–50 of 15,000+

Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Dose of Miridesap in Healthy Japanese Subjects.

This phase 1 study characterized the safety, tolerability, pharmacokinetics, and pharmacodynamics of miridesap (GSK2315698) following an intravenous (IV) infusion in healthy Japanese men. Subjects in Cohort 1 received 1-hour IV infusions of 10, 20, and 40 mg of miridesap or placebo, and subjects in Cohort 2 received a 15-hour IV infusion of 20 mg/h of miridesap or placebo. No treatment-related adverse events were reported. No new safety signals were identified for either vital signs or clinical laboratory ...


Melatonin reduced endometrial hyperplasia induced by estradiol in female albino rats.

Melatonin, the pineal gland hormone, plays a crucial role in regulation of neuroendocrine and defensive functions, free radicals neutralization, and suppresses angiogenesis, proliferation and cancer. The purpose of designing our study is to assess the effect of estradiol benzoate and its combination with melatonin on uteri of female albino rats. For 4 weeks, the present study was conducted on thirty six female rats separated into 3 groups: Control group (rats received the vehicle), EB group (rats were treat...

The endocrine disruptor, 17α-ethinyl estradiol, alters male mate choice in a freshwater fish.

Among the handful of studies on the behavioural effects of endocrine disrupting chemicals (EDCs), only a few have set out to disentangle the mechanisms underpinning behavioural changes. In fish, previous studies have shown that both visual and chemical cues play an important role in mate choice. As such, contaminant-induced changes in either transmission or perception of mate choice cues could have direct implications for individual's fitness. One widespread contaminant of environmental concern is 17α-ethi...


Mucosa-Associated Microbiota in the Gastrointestinal Tract of Healthy Japanese Subjects.

The importance of microbiota infiltrating the gut mucus layer has been reported in the pathogenesis of various gastrointestinal and systemic diseases. However, little is known about the mucosa-associated microbiota (MAM) in healthy subjects. The present study aimed to clarify the characteristics of the gastrointestinal MAM from the oral cavity to the rectum in healthy Japanese subjects.

Sexually experienced, but not naïve, female rats show a conditioned object preference (COP) for mating after a single training trial.

Female rats with mating experience spend more time with the male rat, exhibit shorter contact-return latency to intromission, and display more proceptive behaviors in the male rat's compartment than during the first mating experience. The present study tested 1) whether mating induced conditioned object preference (COP) is possible with a single conditioning trial and 2) whether a preference is induced for an object associated with the first mating encounter or the fifth mating encounter in female rats. Ova...

The pharmacokinetics of dexmedetomidine in patients with obstructive jaundice: A clinical trial.

Dexmedetomidine, a highly selective central α2-agonist, undergoes mainly biotransformation in the liver. The pharmacokinetics of dexmedetomidine were significantly affected by hepatic insufficiency. The clearance of dexmedetomidine in patients with severe hepatic failure decreased by 50% compared with controls. We tested the hypothesis that the pharmacokinetics of dexmedetomidine would be affected by obstructive jaundice. The prospective registration number of clinical trial is ChiCTR-IPR-15007572.

No Clinical Impact of CYP3A5 Gene Polymorphisms on the Pharmacokinetics and/or Efficacy of Maraviroc in Healthy Volunteers and HIV-1-Infected Subjects.

Maraviroc is a C-C chemokine receptor type-5 antagonist approved for the treatment of HIV-1. Previous studies show that cytochrome P450 3A5 (CYP3A5) plays a role in maraviroc metabolism. CYP3A5 is subject to a genetic polymorphism. The presence of 2 functional alleles (CYP3A5*1/*1) confers the extensive metabolism phenotype, which is rare in whites but common in blacks. The effect of CYP3A5 genotype on maraviroc and/or metabolite pharmacokinetics was evaluated in 2 clinical studies: a post hoc analysis from...

The Respiratory Specimen Collection Trial (ReSpeCT): A Randomized Controlled Trial to Compare Quality and Timeliness of Respiratory Sample Collection in the Home by Parents and Healthcare Workers From Children Aged <2 Years.

Most acute respiratory infection (ARI) research focuses on severe disease and overlooks the burden of community-managed illness. For community-based studies, home-based specimen collection by parents could be a resource-saving alternative to collection by healthcare workers (HCWs). In this study, we compared parent and HCW groups for their likelihood to collect specimens and the timeliness and quality of such collection.

Safety, tolerability, and pharmacokinetics of AL-335 in healthy volunteers and hepatitis C virus-infected subjects.

The nucleotide analog AL-335 is a pangenotypic hepatitis C virus (HCV) nonstructural protein (NS)5B inhibitor being evaluated as treatment for chronic HCV infection.

Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability of JNJ-61178104, a Novel Tumor Necrosis Factor-Alpha and Interleukin-17A Bispecific Antibody, in Healthy Subjects.

The safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of JNJ-61178104, a novel anti-tumor necrosis factor-alpha (TNFα) and anti-interleukin-17A (IL-17A) bispecific antibody, were investigated in a placebo-controlled, first-in-human study. Healthy subjects (n = 54) received a single dose of JNJ-61178104 by either intravenous infusion (0.1, 0.3, 1, 3, and 10 mg/kg) or subcutaneous injection (1 mg/kg). Blood samples for measurement of serum JNJ-61178104 concentrations, total IL-...

First-in-Human Studies for a Selective RET Tyrosine Kinase Inhibitor, GSK3179106, to Investigate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers.

Rearranged during transfection (RET), a neuronal growth factor receptor tyrosine kinase, regulates the development of the sympathetic, parasympathetic, motor, and sensory neurons in the enteric nervous system. GSK3179106 is a RET kinase inhibitor that was administered in double-blind, randomized, placebo-controlled single-dose and repeat-dose studies in healthy subjects to investigate its pharmacokinetics and safety/tolerability. In the single-dose study (n = 16), GSK3179106 was dosed from 10 mg to 800 mg, ...

Pharmacokinetics and pharmacokinetic/pharmacodynamic relationship of vicagrel, a novel thienopyridine P2Y inhibitor, compared with clopidogrel in healthy Chinese subjects following single oral dosing.

Vicagrel, a novel thienopyridine antiplatelet agent, is an analogue of clopidogrel in development for the treatment of acute coronary syndromes. This study investigated the pharmacokinetic properties of vicagrel after single oral dosing with a direct comparison with clopidogrel in healthy Chinese subjects in the first two phase I clinical studies. The relationship between the exposure to the active metabolite and the platelet reactivity was also assessed for vicagrel.

Five-Year Randomized Study Demonstrates Blood Pressure Increases in Young Women With Turner Syndrome Regardless of Estradiol Dose.

We evaluated the development in blood pressure (BP) and heart rate in young women with Turner syndrome (TS) and investigated potential influencing cofactors. Twenty TS women (mean±SD, 22.9±2.3 years of age) were investigated in a 5-year prospective setting. Data were derived from a randomized controlled clinical trial investigating 2 different doses of estradiol treatment (2 mg 17β-estradiol per day and placebo or 2+2 mg 17β-estradiol per day). A control group of 12 healthy age-matched young women (mean...

Exploring the role of body mass index in relationship of serum nitric oxide and advanced glycation end products in apparently healthy subjects.

This study aimed to identify any association of serum nitric oxide (NO) and advanced glycation end products (AGEs) with body mass index (BMI) in apparently healthy subjects. In this cross-sectional study, participants were 90 apparently healthy subjects, categorized into three BMI groups as follows: BMI≤19.5 (n = 21), 19.6≤BMI≤24.9 (n = 35), and BMI≥25 (n = 34). Serum levels of NO were measured by griess reaction method. Determination of serum pentosidine and carboxymethyllysine (CML) was done using...

Distribution, Metabolism, and Excretion of Gedatolisib in Healthy Male Volunteers After a Single Intravenous Infusion.

In this open-label study (NCT02142920), we investigated the distribution, pharmacokinetics, and metabolism of the pan-class-I isoform phosphatidylinositol 3-kinase/mammalian target of rapamycin inhibitor gedatolisib (PF-05212384), following a single intravenous administration in healthy male subjects. A single, 89-mg, intravenous dose of gedatolisib was associated with a favorable safety profile in the 6 healthy subjects evaluated. Peak plasma concentrations for unchanged gedatolisib and total radioactivity...

Age- and Diabetes-Related Changes in the Free Fatty Acid Composition of the Human Stratum Corneum.

Of particular importance for Stratum corneum (SC) lipids are the free fatty acids (FFAs). Age-related changes of the SC structure lead to diminished capacity for barrier compensation. The aims of this cross-sectional study were to identify even-numbered especially odd-numbered FFAs within the intercorneocytic lamellar lipid structures of the SC and to explore age- and diabetes-related changes in FFAs. Gas chromatography - flame ionisation detection was used to qualitatively and quantitatively assess FFAs ex...

Mild hypohydration impairs cycle ergometry performance in the heat: A blinded study.

The aim of the present study was to observe the effect of mild hypohydration on exercise performance with subjects blinded to their hydration status. Eleven male cyclists (weight 75.8±6.4 kg, VO : 64.9±5.6 mL·kg ·min , body fat: 12.0±5.8%, Power : 409±40 W) performed three sets of criterium-like cycling, consisting of 20-min steady-state cycling (50% peak power output), each followed by a 5-km time-trial at 3% grade. Following a familiarization trial subjects completed the experimental trials, in coun...

Ultrasonography of the Internal Architecture of the Superficial Part of the Masseter Muscle in Vivo.

It is unclear whether the deep inferior tendon (DIT) is equally present in vivo, and little anatomical information is available regarding the existence and morphology of the DIT in healthy young subjects. The aim of this study was to characterize the DIT of the masseter muscle in healthy young subjects using ultrasonography and to compare the morphology of this tendon with previously reported data for healthy young subjects in order to provide the most-effective injection methods for botulinum neurotoxin tr...

Pharmacokinetics of Anakinra in Subjects of Heavier Versus Lighter Body Weights.

This trial (20010168) studied how body weight (BW) and body mass index (BMI) influenced the PK of anakinra. Subjects (n=32) were assigned to 4 groups (n = 8) according to BW and BMI. Randomization was according to a 4-treatment, 4-period, 4-sequence crossover design. The four anakinra injections were 100, 150, 300 mg sc & 100 mg iv. Plasma samples were measured by ELISA and noncompartmental PK parameters estimated. BW demonstrated the following effects: after IV administration, significant effects (p < 0.05...

Estradiol and progesterone bioavailability for moderate to severe vasomotor symptom treatment and endometrial protection with the continuous-combined regimen of TX-001HR (oral estradiol and progesterone capsules).

In the REPLENISH trial, women receiving TX-001HR-an oral, softgel capsule, combining 17β-estradiol (E2) and progesterone (E2 mg/P4 mg 1/100, 0.5/100), had significantly improved vasomotor symptoms, while having their endometrium protected from hyperplasia. The objective here was to describe P4 levels sufficient to counteract the potential endometrial effects of 1 or 0.5 mg oral E2 with TX-001HR.

Moderate-Intensity Arm-cranking Exercise May not Improve Arterial Function in Healthy Adult Men.

Endurance exercises, such as cycling or running, are useful for improving arterial function. However, people suffering from partial paralysis or arthritis are unable to perform these kinds of lower-limb exercises. In the present study, we explored the acute effect of upper-arm exercise on arterial stiffness in healthy men. Fourteen healthy adult men performed two experimental trials. The order of experiments was randomized between a 30-min arm-cranking exercise at 50% V̇O (A-trial) and a 30-min leg-cycling...

Pharmacokinetics of intramuscular alfaxalone and its echocardiographic, cardiopulmonary and sedative effects in healthy dogs.

The pharmacokinetics and the effects of a single intramuscular (IM) dose of alfaxalone on sedation and cardiopulmonary and echocardiographic variables was studied in dogs. Twelve healthy adult Beagles (3 females, 9 males) were used in this prospective controlled cross-over trial. Echocardiography was performed with and without 4 mg kg-1 alfaxalone IM with a week wash-out interval. Sedation (19-point scale; 0 = no sedation), cardiopulmonary parameters, blood gas analysis and plasma concentration of alfaxalon...

A Randomized, Double-Blind, Placebo-Controlled, First-Time-in-Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of GSK3389404 in Healthy Subjects.

GSK3389404 is a liver-targeted antisense oligonucleotide that inhibits synthesis of hepatitis B surface antigen and all other hepatitis B virus proteins. This first-in-human, randomized, double-blind, phase 1 study assessed the safety and pharmacokinetics of GSK3389404 administered subcutaneously (SC) in healthy subjects. Four single ascending-dose cohorts (10 mg, 30 mg, 60 mg, and 120 mg) and 3 multiple ascending-dose cohorts (30 mg, 60 mg, and 120 mg once weekly for 4 weeks) each comprised 6 subject...

Pharmacokinetics of Single and Repeat Doses of Fluticasone Furoate/Umeclidinium/Vilanterol in Healthy Chinese Adults.

The pharmacokinetics (PK) and safety of single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) after single and repeat dosing in healthy Chinese adults were assessed. In this open-label study (NCT02837380), subjects received once-daily FF/UMEC/VI 100/62.5/25 μg on day 1 and repeat doses on days 2-7. PK parameters (days 1 and 7) included maximum observed concentration (C ) and area under the plasma concentration-time curve (AUC) from time zero (predose) to last time of quantifiable concent...

Pharmacokinetics of Prenylflavonoids following Oral Ingestion of Standardized Epimedium Extract in Humans.

Leaves of the plant are traditionally consumed for bone health and other indications. The aim of this study was to establish the safety and pharmacokinetics of the metabolites of prenylflavonoids (icariin, icariside I, icariside II, icaritin, and desmethylicaritin) following single doses of a defined prenylflavonoid extract in humans. A single oral dose of 370, 740, or 1110 mg of a standardized prenylflavonoid extract was administered to 30 healthy male subjects in a randomized, placebo-controlled tria...


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