Clinical trials: Bioequivalence of the Test Formulation
Healthy
Comparative Bioavailability Study of Lisinopril Tablets, 10 mg
The purpose of this study is to compare the bioavailability of Par Lisinopril 10 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).
- Trial name
- NCT01375244
- Testing
- Lisinopril, Zestril
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Chronic Graft Versus Host Disease
Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants
The purpose of this open-label, randomized, cross-over, Phase 1, 2-treatment, 2-period, 2-sequence study is to assess the bioequivalence of belumosudil oral suspension compared with belumosudil tablet in healthy male participants…
- Trial name
- NCT07726914
- Testing
- Belumosudil
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Sanofi
Peripheral (Sensorimotor) Diabetic Polyneuropathy
To Assess the Bioequivalence of Test Oral Formulation of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Ilko Ilac San. Ve Tic. A.S. Versus Reference Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany.
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San. Ve Tic. A.S.
- Trial name
- NCT04214665
- Testing
- Alpha Lipoic acid 600 mg HR film coated tablets
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ilko Ilac San. ve Tic. A.S.
Healthy
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting conditions.
- Trial name
- NCT00882700
- Testing
- Cefdinir 300 mg Capsule (Sandoz, Austria), Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sandoz
Healthy
Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral dose of the commercially…
- Trial name
- NCT00834795
- Testing
- Carvedilol 25 mg tablets, COREG® 25 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions
The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc.
- Trial name
- NCT00759902
- Testing
- morphine sulfate extended-release capsules, KADIAN (morphine sulfate extended-release) capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250mg/5 ml Oral Suspension Fasting Conditions
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250mg/5 ml fasting conditions.
- Trial name
- NCT00882570
- Testing
- Cefdinir 250 mg/5 ml Oral Suspension (Sandoz, Austria), Omnicef 250 mg/5 ml Oral Suspension of Cefdinir (Abbot Laboratories, USA)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sandoz
Healthy
Cilostazol 100 mg Tablet Formulations Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test cilostazol formulation to an equivalent oral dose of the commercially available cilostazol in a test population of 36…
- Trial name
- NCT00838630
- Testing
- Cilostazol 100 mg tablets, Pletal® 100 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fasting Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available…
- Trial name
- NCT00853216
- Testing
- Oxycodone hydrochloride tablet 30 mg, Roxicodone™ tablet 30 mg
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Therapeutic Equivalency
Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets
The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets) in adult subjects under fasting…
- Trial name
- NCT00685165
- Testing
- Primidone 50 mg Tablet, Primidone (Mysoline®) 50 mg Tablet
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Allergy
To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy
This study is designed to assess bioequivalence between two products used for treatment of allergy.
- Trial name
- NCT01322282
- Testing
- Cetirizine
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fed Conditions
Objective: Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test…
- Trial name
- NCT00939705
- Testing
- topiramate
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir
Bioequivalence study of two formulations containing a fixed dose combination of 600 mg Efavirenz, 200 mg Emtricitabine and 300 mg Tenofovir Disproxyl Fumarate in coated tablets under a single-dose, two-way crossover design.
- Trial name
- NCT03309566
- Testing
- Efavirenz, tenofovir disoproxil fumarate and emtricitabine
- Where
- Argentina
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Laboratorio Elea Phoenix S.A.
Healthy
Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate…
- Trial name
- NCT00829673
- Testing
- Dexmethylphenidate Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence Study
A Phase 1 Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir Study
In a phase 1, open-label, crossover study to evaluate the relative bioavailability of a tablet formulation of ravidasvir (test) versus the capsule formulation of ravidasvir (reference) in 24 healthy adult volunteers (PPI-668-104…
- Trial name
- NCT03602300
- Testing
- Ravidasvir test formulation produced by Doppel, Ravidasvir reference formulation produced by EEPI
- Where
- Malaysia
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Healthy
Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate…
- Trial name
- NCT00829712
- Testing
- Dexmethylphenidate Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices
The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices.
- Trial name
- NCT05810597
- Testing
- Tirzepatide, Single Dose Pen, Multi-use Prefilled Pen
- Where
- 3 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 100 mg Tablets under fed conditions.
- Trial name
- NCT00846885
- Testing
- Sumatriptan Succinate, Imitrex®
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
To Assess the Bioequivalence of Two Pacritinib Drug Product Formulations and FMI Formulation Following Oral Administration in Healthy Subjects
A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT] Formulation [Reference] and Final Market Image [FMI]…
- Trial name
- NCT02823171
- Testing
- Treatment A: 400 mg Pacritinib P3CT, Treatment B: 400 mg of pacritinib FMI
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- CTI BioPharma
Healthy
Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test…
- Trial name
- NCT00840411
- Testing
- Clarithromycin ER 500 mg tablets, BIAXIN® XL 500 mg tablets
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA