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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 1–25 of 16,000+

Evaluation of folic acid supplementation by concomitant administration of ethinyl estradiol + levonorgestrel in healthy female subjects

Folic acid supplementation prevents 50 - 75% of cases of neural tube defects. This study evaluated the folic acid supplementation after oral administration of the ethinyl estradiol 0.02 mg + levonorgestrel 0.10 mg + folic acid 0.4 mg coated tablet as well as its safety and tolerability in healthy female subjects.

Pharmacokinetic and Drug-Drug Interaction Profiles of the Combination of Tezacaftor/Ivacaftor.

Drug-drug interaction (DDI) studies are described for tezacaftor/ivacaftor, a new cystic fibrosis transmembrane conductance regulator modulator therapy for the treatment of cystic fibrosis. Three phase I DDI studies were conducted in healthy subjects to characterize the DDI profile of tezacaftor/ivacaftor with cytochrome P450 (CYP)3A substrates, CYP3A inhibitors, and a permeability glycoprotein (P-gp) substrate. The effects of steady-state tezacaftor/ivacaftor on the pharmacokinetics (PKs) of digoxin (a P-g...

The JAK1 Inhibitor Upadacitinib Has No Effect on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol: A Study in Healthy Female Subjects.

Upadacitinib is a novel selective oral Janus kinase 1 (JAK) inhibitor being developed for treatment of several inflammatory diseases. Oral contraceptives are anticipated to be a common concomitant medication in the target patient populations. This study was designed to evaluate the effect of multiple doses of upadacitinib on the pharmacokinetics of ethinylestradiol and levonorgestrel in healthy female subjects. This phase I, single-center, open-label, 2-period crossover study evaluated the effect of multipl...

Pharmacokinetics, absorption, metabolism, and excretion of Civosidenib (AG-120) in healthy male subjects.

Pharmacokinetics, absorption, metabolism, and excretion of ivosidenib, a mutant isocitrate dehydrogenase-1 inhibitor, were determined in healthy male subjects.

Segesterone acetate/Ethinyl estradiol 12-month contraceptive vaginal system safety evaluation.

To evaluate safety outcomes from clinical studies of a 12-month contraceptive vaginal system (CVS) releasing an average of segesterone acetate (SA) 150 mcg and ethinyl estradiol (EE) 13 mcg daily.

Ataluren Pharmacokinetics in Healthy Japanese and Caucasian Subjects.

To evaluate the potential for ethnicity-related differences in ataluren pharmacokinetics (PK) and safety, a phase 1 single-dose study was conducted in 48 healthy (24 Japanese and 24 Caucasian subjects), nonsmoking male volunteers who were equally divided into 3 cohorts of oral doses at 5, 10, and 20 mg/kg. Blood samples were collected until 48 hours postdose. PK results demonstrated rapid absorption of ataluren, with peak plasma levels (C ) being attained between 0.875 and 2.5 hours after dosing. The mea...

Pharmacokinetics and Pharmacodynamics of the BACE1 Inhibitor Verubecestat (MK-8931) in Healthy Japanese Adults: a Randomized, Placebo-Controlled Study.

BACE1 is required for the production of β-amyloid peptides and considered a potential treatment target for Alzheimer's disease (AD). To support Japan's participation in the global clinical development program, we characterized the safety, pharmacokinetics, and pharmacodynamics of the BACE1 inhibitor verubecestat (MK-8931) in 24 healthy Japanese adults in a 2-part, single-center, randomized, placebo-controlled phase I trial and compared the results with historic data from non-Japanese subjects. Both single ...

Pharmacokinetics, Safety and Tolerability of Tylerdipine Hydrochloride, a Novel Dihydropyridine Dual L/T-type Calcium Channel Blocker, after Single and Multiple Oral Doses in Healthy Chinese Subjects.

Tylerdipine hydrochloride (KBP-5660) is a novel L/T-type dual calcium channel blocker developed for the treatment of hypertension. We aimed to study the pharmacokinetics, safety and tolerability of tylerdipine in healthy Chinese subjects.

Application of Physiologically-Based Pharmacokinetic Modeling to Predict Pharmacokinetics in Healthy Japanese Subjects.

Pharmacokinetics (PK) in Japanese healthy subjects were simulated for nine compounds using physiologically based pharmacokinetic (PBPK) models parameterized with physicochemical properties, preclinical absorption, distribution, metabolism, and excretion (ADME) data, and clinical PK data from non-Japanese subjects. For each dosing regimen, 100 virtual trials were simulated and predicted/observed ratios for C and AUC were calculated. As qualification criteria, it was pre-specified that over 80% of simulated t...

Pharmacokinetics and Safety of Single and Multiple Doses of Rasagiline in Healthy Japanese and Caucasian Subjects.

As of March 2018, rasagiline is approved for the treatment of Parkinson disease in 55 countries including Japan. The present study evaluated the pharmacokinetics (PK) and safety of rasagiline in healthy Japanese and Caucasian subjects following single and multiple administrations of three rasagiline doses. In this double-blind, placebo-controlled study, 64 healthy subjects (32 Japanese and 32 Caucasian) received either rasagiline (0.5, 1.0, or 2.0 mg) or placebo for 10 days with PK sampling for single dose ...

Candidate gene and pathway analyses identifying genetic variations associated with prasugrel pharmacokinetics and pharmacodynamics.

We aimed to investigate the genetic polymorphisms and pharmacogenetic variability associated with the pharmacodynamics (PD) and pharmacokinetics (PK) of prasugrel, in healthy Han Chinese subjects.

Physiologically-Based Pharmacokinetic Modelling to Predict Exposure Differences in Healthy Volunteers and Subjects with Renal Impairment: Ceftazidime Case Study.

Ceftazidime is a widely used β-lactam antibiotic and almost entirely excreted via glomerular filtration in kidney. The objective of this analysis was to assess the ability of physiologically-based pharmacokinetic (PBPK) model to predict ceftazidime exposure in healthy volunteers and subjects with renal impairment. A full PBPK model of ceftazidime was developed using physiochemical properties and clinical data. The total clearance of 115 mL/min and renal clearance of 100 mL/min were obtained from ceftazidim...

Pharmacokinetic Profile of a Generic Formulation of Sofosbuvir and Its Metabolite GS-331007 in Healthy Chinese Subjects.

Sofosbuvir is an NS5B nucleotide inhibitor for the treatment of hepatitis C viral infection. In this study the pharmacokinetics (PK) and safety of single and multiple doses of generic sofosbuvir were investigated in healthy Chinese subjects. Twelve subjects (6 male and 6 female) were enrolled in this study. The PK parameters of sofosbuvir and its metabolite (GS-331007) in both blood and urine samples were analyzed after dosing by the established liquid chromatography tandem mass spectrometry analytical meth...

Pharmacokinetics and subjective effects of a novel oral LSD formulation in healthy subjects.

The aim of the present study was to characterize the pharmacokinetics and exposure-subjective response relationship of a novel oral solution of lysergic acid diethylamide (LSD) that was developed for clinical use in research and patients.

Pharmacokinetics of 10-gingerol and 6-shogaol in the plasma of healthy subjects treated with red ginger ( var. Rubrum) suspension.

Red ginger ( var. Rubrum) is among the most widely consumed medicinal herbs in Indonesia. Ginger rhizome contains phenol compounds including gingerol and shogaol. 10-gingerol has been reported to exhibit the greatest anti-inflammatory and anti-oxidant activities compared with those of other gingerols. Pharmacokinetic studies on ginger have been reported, but there is a lack of such study on red ginger. The present work studied the pharmacokinetics of 10-gingerol and 6-shogaol in the plasma of healthy subjec...

Assessment of Pharmacokinetic, Pharmacodynamic Profile, and Tolerance of Gadopiclenol, A New High Relaxivity GBCA, in Healthy Subjects and Patients With Brain Lesions (Phase I/IIa Study).

The aim of this study was to evaluate the pharmacokinetics, safety profile, and pharmacodynamics of gadopiclenol, a new high relaxivity macrocyclic gadolinium-based contrast agent, in healthy subjects and patients with brain lesions.

Pharmacokinetic Interaction Study Between Saxagliptin and Omeprazole, Famotidine, or Magnesium and Aluminum Hydroxides Plus Simethicone in Healthy Subjects: An Open-Label Randomized Crossover Study.

Saxagliptin is an orally administered, highly potent, and selective dipeptidyl peptidase-4 inhibitor for the management of type 2 diabetes mellitus. This study was conducted to determine the effect of magnesium and aluminum hydroxides plus simethicone, famotidine, and omeprazole on the pharmacokinetics of saxagliptin and its active metabolite, 5-hydroxy saxagliptin. This was an open-label, randomized, 5-treatment, 5-period, 3-way crossover study in 15 healthy subjects. Mean C of saxagliptin was 26% lower, b...

STOP 101: A Phase 1, Randomized, Open-Label, Comparative Bioavailability Study of INP104, Dihydroergotamine Mesylate (DHE) Administered Intranasally by a I123 Precision Olfactory Delivery (POD ) Device, in Healthy Adult Subjects.

Investigate the safety and pharmacokinetics (PK) of INP104, intranasal dihydroergotamine mesylate (DHE) administered via a Precision Olfactory Delivery (POD ) device, (Impel NeuroPharma, Seattle, WA) vs intravenous (IV) DHE and DHE nasal spray (Migranal ) in healthy adult subjects.

Single- and multiple-dose pharmacokinetics of the peripheral non-narcotic antitussive moguisteine in healthy Chinese volunteers.

Moguisteine is a non-narcotic peripheral antitussive drug that has been effective and well-tolerated in clinical studies. The aim of the present work was to investigate the pharmacokinetics of moguisteine given as single or multiple doses to healthy Chinese subjects.

Multiple-Dose Pharmacokinetics, Pharmacodynamics, and Safety of the Urotensin-II Receptor Antagonist Palosuran in Healthy Male Subjects.

To investigate the multiple-dose pharmacokinetics (PK), pharmacodynamics (PD), and tolerability of palosuran, a selective, potent antagonist of the human UT receptor.

Using a semi-mechanistic model to identify the main sources of variability of metformin pharmacokinetics.

Metformin pharmacokinetics (PK) is highly variable and researchers have for years tried to shed light on determinants of inter-individual (IIV) and inter-occasion variability (IOV) of metformin PK. We set out to identify the main sources of PK variability using a semi-mechanistic model. We assessed the influence of subject characteristics, including seven genetic variants. Data from three studies of healthy subjects with PK measurements of plasma and urine after single dose or at steady-state were used in t...

Development of the Metabolic Syndrome: Study Design and Baseline Data of the Lufthansa Prevention Study (LUPS), A Prospective Observational Cohort Survey.

The (LUPS) study is a prospective observation of a healthy worker cohort to identify early changes in metabolism leading to the Metabolic Syndrome (MetS) and to analyze their relation to behavioral factors like nutrition, physical activity, psychological status, and to underlying genetic conditions. The LUPS study recruited a sample of 1.962 non-diabetic healthy adults between 25-60 years, employed at a flight base of Lufthansa Technik GmbH in Hamburg, Germany. Baseline assessments included anthropometric ...

Assessment of the Effects of Age and Renal Function on Pharmacokinetics of Bazedoxifene in Postmenopausal Women.

Bazedoxifene (BZA), a chemically distinct selective estrogen receptor modulator, has demonstrated efficacy and long-term safety in phase 3 placebo-controlled studies for prevention and treatment of osteoporosis. Here, we assessed the potential effects of age and renal function on BZA pharmacokinetics in healthy postmenopausal women (aged 55-84 years; CLcr, 32-109 mL/min). This was an open-label, single-dose, parallel, nonrandomized inpatient study conducted in healthy postmenopausal women and postmenopausal...

Effects of hypnotics on prefrontal cortex activity during a verbal fluency task in healthy male subjects: A near-infrared spectroscopy study.

To assess the effects of hypnotics on prefrontal cortex activity in healthy subjects using near-infrared spectroscopy (NIRS) in a double-blind, placebo-controlled crossover trial.

Doppler analysis of ovarian stromal blood flow changes after treatment with metformin versus ethinyl estradiol-cyproterone acetate in women with polycystic ovarian syndrome: A randomized controlled trial.

To evaluate the effects of oral contraceptive pill (OCP) and Metformin at the end of 6 months of treatment on ovarian stromal blood flow by using pulsed and color Doppler in women with PCOS.

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