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Bioequivalence clinical trials

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NCT ID: NCT03821480 Completed - Bioequivalence Clinical Trials

Diflucan Bioequivalence Study For Transferring The Manufacture

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

This study is to assess the bioequivalence between fluconazole 50mg capsules from two different manufacturers. This is a open-label, randomized, single dose, 2-treatment, 2-period crossover study in healthy Korean male and female subjects aged 19-55, to assess the bioequivalence after taking study drugs.

NCT ID: NCT03820180 Completed - Bioequivalence Clinical Trials

A Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers

Start date: January 23, 2019
Phase: Phase 1
Study type: Interventional

Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder

NCT ID: NCT03799536 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions

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

This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.The study was conducted in multiple groups.

NCT ID: NCT03751202 Completed - Bioequivalence Clinical Trials

A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. ADVAIR DISKUS® in Healthy Volunteers

BREATH-PK500
Start date: November 20, 2018
Phase: Phase 1
Study type: Interventional

Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder

NCT ID: NCT03749733 Withdrawn - Bioequivalence Clinical Trials

Bioequivalence of Two Fixed-dose Combination Tablets Containing Estradiol and Nomegestrol Acetate

Start date: October 2019
Phase: Phase 1
Study type: Interventional

This study will investigate the bioavailability in fasting post-menopausal women of 2 film-coated tablet formulations containing 1.5 milligrams (mg) of estradiol and 2.5 mg of nomegestrol acetate. The study will be performed at a single site. Participants will take a single oral dose of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 21 days between each study period.

NCT ID: NCT03708133 Completed - Bioequivalence Clinical Trials

Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation

Start date: December 5, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of the current study is to investigate the bioequivalence of a newly developed 120 mg nifurtimox tablet formulation (Test treatment) compared with the 120 mg nifurtimox tablet currently used in the Bayer pediatric clinical development program (Reference treatment). The new tablet formulation assessed in this study is intended to replace the 120 mg nifurtimox tablet formulation currently used in clinical practice. It is an immediate-release tablet with an altered composition compared to the reference formulation. The new tablet overcomes pharmaceutical quality issues seen for the current formulation, e.g. sensitivity to humidity. Due to safety reasons, the study drug will be administered under fed conditions to adult male and female patients suffering from Chagas' disease and not healthy subjects (see also Benefit-risk assessment below). In addition, the PK, safety, and tolerability of nifurtimox will be assessed as secondary objectives.

NCT ID: NCT03705533 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State

Start date: September 7, 2018
Phase: Phase 1
Study type: Interventional

This single center, randomized, single dose, full replicate, crossover comparative laboratory-blinded study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of telmisartan 80 mg tablets after oral administration under fasting conditions.

NCT ID: NCT03702894 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions

Start date: September 21, 2018
Phase: Phase 1
Study type: Interventional

This was an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.The study was conducted in multiple groups.

NCT ID: NCT03659435 Completed - Bioequivalence Clinical Trials

Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (9.5mg/24h)

Start date: August 22, 2018
Phase: Phase 1
Study type: Interventional

The present clinical trial will be conducted in order to compare the bioavailability of rivastigmine and to assess bioequivalence at steady-state of the Test product RID-TDS 9.5 mg/24 h (Luye Pharma AG, Germany) and the marketed Reference product Exelon® 9.5 mg/24 h transdermales Pflaster (Novartis Pharma GmbH, Germany) after multiple patch application. Each of both treatments will last for 11 days with a washout period of 14 days between the treatments.

NCT ID: NCT03646331 Completed - Bioequivalence Clinical Trials

Bioequivalence of Imeglimin Tablet Formulations

Start date: September 3, 2018
Phase: Phase 1
Study type: Interventional

This is an open-label assessment of the bioequivalence of two 500 mg-tablet formulations of imeglimin (Tablet A [reference product] and Tablet B [test product]), in at least 16 healthy Caucasian volunteers.