Clinical Trials About "ChemOutsourcing 2017 Expands Beyond Into Pharmaceutical Ingredient Supply" RSS

03:47 EDT 23rd October 2017 | BioPortfolio

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Showing "ChemOutsourcing 2017 Expands Beyond Into Pharmaceutical Ingredient Supply" Clinical Trials 1–25 of 1,000+


Single and Repeated Dose Escalation Study of GSK2838232

GSK2838232 is a Human Immunodeficiency Virus (HIV) maturation inhibitor being developed for the treatment of HIV in combination with other antiretroviral therapy (ART). The primary objectives of this study are to investigate the safety, tolerability, and pharmacokinetics (PK) of single and repeat doses of GSK2838232. This study will be a double-blind, placebo-controlled, single and repeat dose escalation study. This study will be conducted in two Parts: single escalating doses ...

A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)

To determine the safety and tolerability of single oral doses of HPN-100 as a formulation (GT4P-F) and GT4P as the active pharmaceutical ingredient (GT4P-API) administered to healthy male subjects.

Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient

The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single dose.

Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone

The purpose of this study is to evaluate the bioavailability and the bioequivalence between two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage strengths (25 mg and 50 mg) after a single oral dose administration under fasting conditions in healthy male and female subjects.

Pharmaceutical Care for Asthma Control Improvement (PHARMACI)-Study

The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients.

The Impact of Pack Supply on Birth Control Pill Continuation

The purpose of this study is to determine whether getting more packs of birth control pills leads to improved continuation, when compared with getting the traditional supply.

Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial

The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for diabetes type 2 patients. Patients will be randomly allocated to the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical care at baseline and follow-up visits over 6 months).

A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C

The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects

Improving Compliance Among Elderly Polypharmacy Users Through Community Pharmacy Based Pharmaceutical Care Program

The aim of the project is to evaluate effectiveness of a multidimensional pharmaceutical care plan in improving compliance among elderly polypharmacy users at community pharmacy settings. The specific objective of the project is to determine effects of pharmaceutical care program on medication adherence and persistence among elderly polypharmacy users.

Impact of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older

The primary objective of this study is to evaluate the impact of the implementation of collaborative pharmaceutical care on drug support at admission for patients 65 years of age and older. This is a cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention every fifteen days after the start of inclusions.

Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations

The aim of the study is to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults 18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age. Primary Observational Objectives - To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < ...

Pharmaceutical Care Service in Diabetes

The purpose of this study is to examine the effectiveness of pharmaceutical care service in the management of poorly controlled type 2 diabetes mellitus.

Sanofi 2017 H7N9 With/Without AS03 in Adults/Elderly

This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females 19 years and older that is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine (2017 H7N9 IIV) administered at different dosages given with or without AS03 adjuvant. Eligible subjects will be randomized into 5 study groups, stratified by age. The study will enroll up to 420 individuals 19-64 yea...

Medication Assessment Through Real Time Information eXchange - Distributed Pharmaceutical Record System

The aim of MATRIX-DPRS is to assess the clinical and organizational impacts of the use of the medication record, opened, filled and managed by pharmacists (from private office and hospital units) by hospital physicians in private and public healthcare establishments (volunteers), for three clinical contexts: anaesthesiology visit before surgery, medications abuse and emergency hospitalization, medications and elderly hospitalisations.

The Australian Parental Supply of Alcohol Longitudinal Study (APSALS)

Parents can positively influence their children's alcohol use. One strategy they use is to provide their children with alcohol, believing it is the best way to teach their children how to drink responsibly. The impact of parental supply is not well understood and may be unintentionally harmful. This study will research the consequences of parental supply within the broader context of parent, child and peer relationships. It will help to determine how parental supply influences ...

The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation

The aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.

Evaluate the Effectiveness and Safety of DPCP Ointment (Samcyprone™) on the Clearance of Verruca Vulgaris (Common Warts)

Warts are benign epidermal tumors caused by human papillomaviruses (HPVs). The active pharmaceutical ingredient DPCP has been used for many years as a compounded formulation in acetone for the treatment of warts, alopecia areata and more recently, cutaneous metastatic melanoma lesions. An improved topical ointment formulation of DPCP called Samcyprone™ will be evaluated for the treatment of common warts.

Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions

The objective of this study is to evaluate the comparative bioavailability between tamsulosin hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.; distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg capsules (Manufactured by Yamanouchi Pharmaceutical Co., Japan; distributed by Boehringer Ingelheim Pharmaceutical Inc. USA), after a single-dose in healthy subjects under fed conditions.

Evaluation of the Cardiac Effects of a Novel Food Ingredient in Healthy Male Subjects

This study evaluates if a single oral dose of 150 mg of the novel food ingredient (AME001, R,R-monatin) does not have an effect on the Fridericia-corrected QT ECG interval (QTcF) exceeding 10 milliseconds (msec). Each subject will consume test article (150 mg), placebo, and moxifloxacin (400 mg; positive control) in each of 3 treatment periods.

Magnetic Resonance Imaging to Assess Changes in Meniscus Vascularity

The menisci in the knee joint are important for normal functioning of the knee. Meniscus tears are amongst the commonest of injuries to the knee. The pattern and blood supply of the meniscus tears determines the treatment plan and outcome. The surgeon identifies the blood supply to the meniscus tear area during the arthroscopy(key hole operation) and decides the treatment option ie repair versus partial meniscectomy. This study aims to identify any changes that occur in the ...

Self-management of Low Molecular Weight Heparin Therapy

There is very little data available on compliance with self-injected low molecular weight heparins (LMWH), but what there is, definitely shows that compliance represents a significant problem. We therefore aim to a) record drug use problems of patients including compliance, b) develop a "SOP" for first instruction by a pharmacist and for subsequent pharmaceutical care and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control) provided in the phar...

Bioequivalence of Two Different Sources of Eslicarbazepine Acetate

The purpose of this study is to determine whether the test product, eslicarbazepine acetate 800 mg tablets (test 1, To be marketed (TBM) Treatment A), and the reference product, eslicarbazepine acetate 800 mg tablets (current Active pharmaceutical ingredient (API) source - Marketed formulation (MF)) (Reference, Treatment C), are bioequivalent and to demonstrate dose equivalence between eslicarbazepine acetate 4 x 200 mg tablets (test 2, TBM Treatment B) and eslicarbazepine acet...

Preventing Falls Through Enhanced Pharmaceutical Care

The objective of the proposed study is to reduce the incidence of falls and fall-related injuries among community-dwelling older adults by better utilizing community pharmacists to advise patients and physicians on medication management.

A Study of the Effect of Particle Size, Formulation and Food on the Pharmacokinetics of GDC-0032 in Healthy Volunteers

This 4-part study will assess the effect of formulation, food, and active pharmaceutical ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period crossover studies. Subjects will receive single doses of GDC-0032 capsule or tablet formulation, in the fasted or fed state.

Effects of Functional Ingredients in an Acute Metabolic Challenge Context

After an energy-rich meal the blood levels of glucose and lipids undergo a marked temporary increase, triggering a wave of oxidative stress due to the appearance of excess free radicals in adipose and muscle tissues. Elevated postprandial hypertriglyceridemia has been associated with increased risk of cardiovascular disease and type 2 diabetes. Hence, postprandial changes in different circulating biomarkers are potential predictors of cardiometabolic risk. In addition to the po...

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