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Pharmacokinetics clinical trials

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NCT ID: NCT04183192 Completed - Healthy Subjects Clinical Trials

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists

Start date: February 17, 2020
Phase: Phase 1
Study type: Interventional

This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (mepolizumab or reslizumab) or placebo.

NCT ID: NCT04181008 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers

Start date: September 28, 2020
Phase: Early Phase 1
Study type: Interventional

This study is a single-center, open-label study of the plasma pharmacokinetics of amiloride nasal spray at three different doses in healthy volunteers.

NCT ID: NCT04176367 Completed - Pharmacokinetics Clinical Trials

An Bioequivalence Study Comparing Nicergoline 10 mg Tablet Manufactured in China With Nicergoline 10 mg Tablet Manufactured in Italy Under Fasted and Fed Conditions in Healthy Chinese Participants

Start date: December 17, 2019
Phase: Phase 1
Study type: Interventional

This trial is a bioequivalence study to support a generic consistency evaluation program, initiated by the China Food and Drug Administration (CFDA) in 2015, for the evaluation of quality and efficacy of the products manufactured in China. Related guidance was issued by Center for Drug Evaluation (CDE) on 27 Nov 2015 named "Use pharmacokinetic (PK) parameter as endpoint for chemical generics bioequivalence (BE) study". Nicergoline localized product is manufactured at Pfizer Dalian China, while the reference product is manufactured at Pfizer Italia S.r.l., Italy. The selected strength of 10 mg tablet is the marketed strength in China, and the selected dose of 30 mg (3 x 10 mg tablet) is one of the commonly used clinically approved daily doses with good tolerability profile. In each group, participants will be randomized to one of the 2 treatment sequences according to a computer generated randomization schedule. Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between the first day of each period.

NCT ID: NCT04100759 Completed - Smoking Clinical Trials

A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers

Start date: June 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Smokers are at higher risk of developing Erectile dysfunction (ED) independent of age and comorbidities. Sildenafil is a cytochrome p3A4 (CYP3A4) substrate used for enhancing the erectile function in males. The study purpose is to determine the effect of smoking on male sexual function based on the international index of erectile function score (IIEF) and investigate the effect of smoking (Cigarettes or marijuana) on the pharmacokinetics and pharmacodynamics of sildenafil.

NCT ID: NCT04092751 Completed - Pharmacokinetics Clinical Trials

Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects

Start date: November 22, 2019
Phase: Phase 1
Study type: Interventional

This is an Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Effect of Oral Doses of SCY-078 (Ibrexafungerp) on the Pharmacokinetics of Pravastatin Administered Orally to Healthy Subjects

NCT ID: NCT04092725 Completed - Pharmacokinetics Clinical Trials

Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects

Start date: September 9, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1 open-label, randomized, two-period, crossover study to evaluate the effect of repeated oral doses of SCY-078 (Ibrexafungerp) on the pharmacokinetics of dabigatran administered orally to healthy subjects.

NCT ID: NCT04023760 Completed - Pharmacokinetics Clinical Trials

Drug Interaction Study of Apixaban With Cyclosporine or Tacrolimus in Transplant Recipients

ACT-KLR
Start date: June 26, 2019
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the pharmacokinetics (PK) of apixaban in kidney and lung transplant recipients stabilized on either cyclosporine or tacrolimus as part of their immunosuppressive therapy.

NCT ID: NCT04004195 Completed - Pharmacokinetics Clinical Trials

Study to Investigate Safety, Absorption, Elimination, and Drug Effect of BAY2327949 in Participants With Different Renal Function Status

Start date: July 10, 2019
Phase: Phase 1
Study type: Interventional

BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. An additional important goal of this study is to gain more information on how well the study drug is tolerated and its effect on the human body functions. The study will enroll healthy participants or patients with mild, moderate or severe reduced kidney functions matched for age, weight and gender. The results of this study will help researchers to select the best dosing of the study drug for future studies in patients.

NCT ID: NCT03967964 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA)

Start date: November 20, 2015
Phase: Phase 1
Study type: Interventional

This study was performed to determine the pharmacokinetic parameters of vaginal rings that contain DHEA, testosterone, or combinations of both androgens, in comparison to the oral administration of DHEA and the transdermal administration of testosterone.

NCT ID: NCT03956134 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetic Characterization of Two Novel CG5503 Tablet Formulations in Healthy Volunteers

Start date: April 2005
Phase: Phase 1
Study type: Interventional

This study investigated the pharmacokinetics (how a drug is taken up and excreted from the body), safety, and tolerability of 2 new tapentadol (CG5503) tablet formulations compared to a previously characterized tapentadol prolonged-release (PR) tablet formulation.