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Bioequivalence clinical trials

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NCT ID: NCT05982990 Active, not recruiting - Bioequivalence Clinical Trials

Bioequivalence Study for Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers

Start date: August 1, 2023
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: NCT05940909 Recruiting - Bioequivalence Clinical Trials

Bioequivalence Study of Perindopril /Amlodipine/Indapamide 8 mg (10 mg)/2.5 mg/10 mg Tablets in Healthy Volunteers Under Fasting Conditions

Start date: June 24, 2023
Phase: Phase 1
Study type: Interventional

This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Triplixam®, 10 mg/2.5 mg/10 mg tablets) or the test (Perindopril Erbumine/ 8 mg/2.5 mg/10 mg Tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

NCT ID: NCT05934799 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting Conditions

Start date: June 16, 2023
Phase: Phase 1
Study type: Interventional

This is an open-labeled, randomized, four period, single-center, crossover, full replicative, comparative study, where each participant will be randomly assigned to the reference (Plavix®, 75 mg film-coated tablets) or the test (Clopidogrel, 75 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

NCT ID: NCT05913921 Completed - Bioequivalence Clinical Trials

Bioequivalence of Amphotericin B Liposome for Injection

Start date: June 2, 2023
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the bioequivalence of two different amphotericin B liposome for injection after single IV infusion at the same dose in normal healthy subjects.

NCT ID: NCT05883124 Completed - Bioequivalence Clinical Trials

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

Start date: April 17, 2023
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 marketed Test product Rivastigmine twice-weekly 9,5 mg/24 h transdermal patch (Manufacturer: Luye Pharma AG, Germany) and the marketed Reference product Exelon® 9.5 mg/24 h transdermal patch (Manufacturer: LTS Lohmann Therapie-Systeme AG, Germany) after multiple patch applications. Each of both treatments will last for 11 days with a washout period of at least 14 treatment-free days between the treatments.

NCT ID: NCT05817435 Completed - Bioequivalence Clinical Trials

A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults

Start date: March 13, 2023
Phase: Phase 1
Study type: Interventional

This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe in healthy participants.

NCT ID: NCT05697003 Active, not recruiting - Bioequivalence Clinical Trials

Bioequivalence Study for Fluticasone Propionate 100 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers

Start date: February 17, 2023
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: NCT05685277 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Tablets Ramipril/Hydrochlorothiazide 10 mg/25 mg in Healthy Volunteers Under Fasting Conditions

Start date: December 28, 2022
Phase: Phase 1
Study type: Interventional

This is an open-labeled, with blinding bioanalytical stage, randomized, two period, two sequences, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Tritace® Plus, 10 mg/25 mg tablets) or the test (Ramipril/Hydrochlorothiazide, 10 mg/25 mg tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

NCT ID: NCT05663398 Completed - Healthy Subjects Clinical Trials

Bioequivalence Study of Test and Reference 400 mg Ibuprofen Coated Tablets in Healthy Volunteers

Start date: May 17, 2022
Phase: Phase 1
Study type: Interventional

This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Darfen 400, 400 mg ibuprofen coated tablets [512 mg ibuprofen sodium dihydrate], manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and Reference medicinal product (marketed medicinal product Nurofen® Forte Express, 400 mg ibuprofen coated tablets [512 mg ibuprofen sodium dihydrate], manufactured by Reckitt Benckiser [Poland] S.A.) in healthy volunteers.

NCT ID: NCT05663372 Completed - Healthy Subjects Clinical Trials

Bioequivalence Study of Test and Reference 50 mg Eplerenone Film-coated Tablets in Healthy Volunteers

Start date: December 7, 2021
Phase: Phase 1
Study type: Interventional

This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Efez 50 mg eplerenone film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa", Ukraine) and Reference medicinal product (marketed medicinal product INSPRA® 50 mg eplerenone film-coated tablets, Marketing Authorisation Holder: Pfizer Europe MA EEIG, Belgium) in healthy volunteers.