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Bioequivalence clinical trials

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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: NCT04819438 Completed - Bioequivalence Clinical Trials

Riluzole Orodispersible Film Replicate Bioavailability

Start date: January 15, 2021
Phase: Phase 1
Study type: Interventional

The objective of the study is to compare the pharmacokinetic profile of riluzole after replicate single dose of the novel orodispersible film test formulation and of the marketed reference Rilutek® tablets and to evaluate their bioequivalence. The subjects will receive single oral doses of 50 mg of riluzole, as test orodispersible film and reference film-coated tablets under fasting conditions, in each of 4 subsequent periods separated by wash-out intervals of at least 7 days between consecutive administrations, according to a 2-treatment, 4-period, replicate cross-over design.

NCT ID: NCT04768985 Completed - Bioequivalence Clinical Trials

Study to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule

Start date: February 25, 2021
Phase: Phase 1
Study type: Interventional

This study is a multicenter, Phase I, open-label, randomized, 2-sequence, 2-treatment, 2-period, crossover, bioequivalence study with single doses of acalabrutinib administered orally in healthy participants. The study is designed to demonstrate the bioequivalence of acalabrutinib tablet (Treatment A) compared with marketed acalabrutinib capsule (Treatment B) in the fasted state.

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: NCT04751318 Completed - Bioequivalence Clinical Trials

Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Feeding Conditions

Start date: February 27, 2021
Phase: Phase 1
Study type: Interventional

This Study will investigate the bioavailability in fasting subjects of 1 capsule formulation containing Duloxetine 60 mg. The Study will be performed at a single site with 36 subjects.Participants will take 1 capsule 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 14 days between each study period.

NCT ID: NCT04746040 Active, not recruiting - Asthma 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 18, 2021
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: 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: NCT04723238 Completed - Bioequivalence Clinical Trials

Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions

Start date: January 23, 2021
Phase: Phase 1
Study type: Interventional

This Study will investigate the bioavailability in fasting subjects of 1 capsule formulation containing Duloxetine 60 mg. The Study will be performed at a single site with 36 subjects. Participants will take 1 capsule 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 14 days between each study period.

NCT ID: NCT04713904 Completed - Bioequivalence Clinical Trials

Bioavailability of Clormadinone/Ethinyl Estradiol Tablets 2 mg/0.02 mg With Regards to Reference Product

Start date: January 16, 2021
Phase: Phase 1
Study type: Interventional

The study will be performed at a single site with 38 subjects. Participantswill take 2 tablets 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 14 days between each study period.

NCT ID: NCT04689919 Completed - Bioequivalence Clinical Trials

Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions

Bioequivalence
Start date: February 19, 2022
Phase: Phase 1
Study type: Interventional

A single center, open label, randomized, single-dose, two period, Two way cross-over study to explore the Bioequivalence of Test Product Xaroban (Rivaroxaban) 20 mg Tablet with the reference product Xarelto (Rivaroxaban) 20 mg tablet under fed conditions in healthy Pakistani male subjects. Subjects will receive one single dose per treatment period separated by a wash-out period of 7 days. Blood samples will be taken up to 48hours post-dose.