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Bioequivalence clinical trials

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NCT ID: NCT06331715 Not yet recruiting - Bioequivalence Clinical Trials

Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg

Start date: May 6, 2024
Phase: Phase 4
Study type: Interventional

An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of Pfizer Europe (Belgium) in healthy, adult, human subjects under fed condition.

NCT ID: NCT05497063 Not yet recruiting - Bioequivalence Clinical Trials

Bioequivalence Study of Sulfadoxine/ Pyrimethamine Dispersible Tablets in Healthy Subjects Under Fasting Conditions

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

To asses bio equivalence between two (500 mg sulfadoxine / 25 mg pyrimethamine) formulation

NCT ID: NCT05218616 Not yet recruiting - Bioequivalence Clinical Trials

The Bioequivalence Study of Two Sunitinib Products in Capsules 50 mg in Healthy Volunteers Under Fasting Conditions

Start date: January 21, 2022
Phase: Phase 1
Study type: Interventional

The study is designed in accordance with the Eurasian Economic Union (EAEU) regulatory guidelines, with the aim of characterizing the bioavailability of two pharmaceutical products of sunitinib in healthy adult volunteers. Within the clinical portion of the study, each volunteer will receive a single oral dose of the test and the reference product in compliance with the generated randomization code.

NCT ID: NCT04882826 Not yet recruiting - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Sildenafil Tablet 100 mg in Healthy Male Volunteers Under Fasting Conditions

Start date: May 10, 2021
Phase: Phase 1
Study type: Interventional

This is an open-labeled (laboratory blinded), randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Viagra®, 100 mg film-coated tablets) or the test (Sildenafil, 100 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: NCT04830579 Not yet recruiting - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Etoricoxib Tablets 120 mg in Healthy Volunteers Under Fasting Conditions

Start date: April 10, 2021
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 (Arcoxia®, 120 mg film-coated tablets) or the test (Etoricoxib, 120 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: NCT04753489 Not yet recruiting - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 10 mg in Healthy Male Volunteers in Fasting Conditions

Start date: February 13, 2021
Phase: Phase 1
Study type: Interventional

This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 10 mg film-coated tablets) or the test (Rivaroxaban, 10 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: NCT04729998 Not yet recruiting - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 20 mg in Healthy Male Volunteers Under Fed Conditions

Start date: January 30, 2021
Phase: Phase 1
Study type: Interventional

This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 20 mg film-coated tablets) or the test (Rivaroxaban, 20 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: NCT04577469 Not yet recruiting - Bioequivalence Clinical Trials

Bioequivalence Study of Sulfadoxine/ Pyrimethamine Tablets in Healthy Subjects Under Fasting Conditions

Start date: December 2020
Phase: Phase 1
Study type: Interventional

To asses bio equivalence between two (500 mg sulfadoxine / 25 mg pyrimethamine) formulation.

NCT ID: NCT04527484 Not yet recruiting - Bioequivalence Clinical Trials

A Bioequivalence Study to Compare Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects

Start date: August 20, 2020
Phase: Phase 1
Study type: Interventional

This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate bioequivalence of two formulations of SHR-1314. Subjects will be randomly assigned to the Vials group, the PFS group at a ratio of 1:1