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Bioequivalence clinical trials

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NCT ID: NCT05076474 Completed - Bioequivalence Clinical Trials

Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

The study will start with a run-in period with controlled diet and no drug for 5 consecutive days. This is to accustom the subjects to the standardized diet and also to determine baseline fecal fat excretion. After run-in period, subjects will be randomized to receive either test or reference orlistat formulations (60 mg or 120 mg) thrice daily under fed conditions for 10 consecutive days.

NCT ID: NCT05061901 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions

Start date: October 6, 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 (Zestril®, 20 mg) or the test (Lisinopril, 20 mg) 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: NCT05055752 Completed - Bioequivalence Clinical Trials

Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.

Start date: May 7, 2020
Phase: Phase 1
Study type: Interventional

This trial is a randomized, actively-controlled, open-label, 2-way crossover bioequivalence study to determine PK parameters following treatment with test aspirin product (PL-ASA capsules) and reference aspirin product (IR-ASA tablets) administered at a single dose of 325 mg.

NCT ID: NCT05021887 Recruiting - Asthma Clinical Trials

A Bioequivalence Study Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions

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

Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder

NCT ID: NCT05014490 Completed - Healthy Subjects Clinical Trials

Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers

Start date: February 24, 2021
Phase: Phase 1
Study type: Interventional

The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product Arcoxia® 120 mg etoricoxib film-coated tablets, Marketing Authorisation Holder: UAB "Merck Sharp&Dohme", Lithuania) in healthy volunteers.

NCT ID: NCT04993222 Completed - Bioequivalence Clinical Trials

A Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects

Start date: June 4, 2020
Phase: Phase 1
Study type: Interventional

The 2 × 2 crossover designed 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: NCT04938856 Completed - Bioequivalence Clinical Trials

Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions

BE
Start date: September 4, 2020
Phase: Phase 1
Study type: Interventional

Single oral administrations of study drug (Lamnet and Lamictal) in two periods separated by a washout period of 14 days. The washout period will be calculated from day of dosing (Day 2) to at least 14 days post dose in each period.

NCT ID: NCT04921566 Completed - Bioequivalence Clinical Trials

Bioequivalence Study of Two Formulations of Torasemide Tablet 10 mg in Healthy Volunteers Under Fasting Conditions

Start date: June 5, 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 (Toradiur®, 10 mg) or the test (Torasemide, 10 mg) 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: NCT04889599 Completed - Bioequivalence Clinical Trials

A Bioequivalence Study of Docetaxel Injection in Patients With Solid Tumours

Start date: April 29, 2021
Phase: Phase 3
Study type: Interventional

The study will be conducted in patients with solid tumors for whom single-agent docetaxel, in the dose of 75 mg/m2, is a suitable treatment option. Each patient, meeting all the inclusion criteria and none of the exclusion criteria, will receive test or reference product in a cross over manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 22 (Period II)

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