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Pharmacokinetics clinical trials

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NCT ID: NCT05125640 Completed - Pharmacokinetics Clinical Trials

Fasting Bioequivalence Study of 2 Oral Progesterone Soft Capsules 200 mg in 48 Healthy Female Subjects

Start date: December 13, 2019
Phase: Phase 1
Study type: Interventional

This study was designed to assess the bioequivalence of single oral dose of Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) Versus Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) In healthy female subjects under fasting conditions

NCT ID: NCT05125627 Completed - Pharmacokinetics Clinical Trials

Fasting Bioequivalence Study of 2 Progesterone Soft Capsules 200 mg in 66 Healthy Female Subjects Under Vaginal Route

Start date: August 28, 2019
Phase: Phase 1
Study type: Interventional

This study was designed to assess the bioequivalence of Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) versus Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) after a single Vaginal dose in healthy female subjects under fasting conditions.

NCT ID: NCT05125588 Completed - Pharmacokinetics Clinical Trials

Fasting Comparative Bioavailability Study of 2 Meloxicam 15 mg Tablets in Healthy Volunteers Under Fasting Condition

Start date: January 29, 2014
Phase: Phase 1
Study type: Interventional

The aim of the study was to compare the bioavailability of two formulations of meloxicam given to healthy volunteers and to demonstrate bioequivalence. The test product, Reumoxicam® 15 mg tablets (Farmak PJSC, Ukraine), given in a single dose was compared with a licensed reference product Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece), in a randomized, laboratory-blind, single dose, two periods, crossover study. The secondary objective of the trial was to investigate the safety of both preparations on the basis of safety clinical and laboratory examinations (at the beginning and at the end of the trial) and registration of adverse events and/ or adverse drug reactions.

NCT ID: NCT05125575 Completed - Pharmacokinetics Clinical Trials

Fed Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers

Start date: January 11, 2019
Phase: Phase 1
Study type: Interventional

This study was designed to compare the bioavailability of the Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under fed conditions.

NCT ID: NCT05125549 Completed - Pharmacokinetics Clinical Trials

Fasted Bioequivalence Study of Clopidogrel Film-coated Tablets, 75 mg in 48 Healthy, Adult Male and Female Subjects.

Start date: July 12, 2018
Phase: Phase 1
Study type: Interventional

This study was designed to compare bioequivalence of the Test Product Clopidogrel bisulfate, film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France) in healthy male and female volunteers under fasting conditions.

NCT ID: NCT05124730 Completed - Pharmacokinetics Clinical Trials

Fasting Bioequivalence Study of 2 Metformin 500 mg Prolonged Release Tablets in 44 Healthy Male and Female Volunteers

Start date: May 21, 2021
Phase: Phase 1
Study type: Interventional

This study was designed to compare the bioavailability of the Test Product Metformin 500mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 500 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under fasting conditions.

NCT ID: NCT05124717 Completed - Pharmacokinetics Clinical Trials

Fed Bioequivalence Study of 2 Metformin 500 mg Prolongued Release Tablets in 28 Healthy Male and Female Volunteers

Start date: June 25, 2019
Phase: Phase 1
Study type: Interventional

The objective of the study is to compare the bioavailability of the Test and Reference products both containing Metformin 500 mg prolonged release tablets (MFM) in healthy male and female volunteers under fed conditions and to assess the bioequivalence of these products based on confidence acceptance intervals of 80.00% to 125.00% for AUC(o-t)and Cmax of MFM as primary endpoints.

NCT ID: NCT05123976 Completed - Pharmacokinetics Clinical Trials

Fasted Bioequivalence Study of 2 Olanzapine Film-coated Tablets, 5 mg, in Healthy, Adult Male and Female Subjects.

Start date: October 21, 2020
Phase: Phase 1
Study type: Interventional

This study was designed to assess the bioequivalence of Olanzapine tablets of two different manufacturers and to investigate the safety and tolerability of Olanzapine tablets of two different manufacturers.

NCT ID: NCT05123781 Completed - Pharmacokinetics Clinical Trials

Fasting Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers

Start date: April 3, 2019
Phase: Phase 1
Study type: Interventional

The primary objective was to compare the rate and extent of absorption of Metformin XR after administration of a Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK), administered as a single dose in healthy subjects under fasting conditions. The adverse events, physical examinations and vital signs were reported for the evaluation of safety.

NCT ID: NCT05099510 Recruiting - Pharmacokinetics Clinical Trials

Natrunix Safety PK Study in Healthy Volunteers

Start date: January 19, 2022
Phase: Phase 1
Study type: Interventional

This trial will be a Phase I Open Label, Placebo-controlled Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Natrunix via Subcutaneous Injection in Healthy Subjects. The target enrollment is 8 healthy subjects per cohort (including six for Natrunix and two for placebo). Three cohorts for a total of 24 healthy volunteers.