Clinical trials: Therapeutic Equivalency
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.
Glaucoma, Open-Angle, Ocular Hypertension
Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.
This is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle…
- Trial name
- NCT05401357
- Testing
- Test - Bimatoprost 0.01% Ophthalmic Solution, Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)
- Where
- 9 sites in United States
- Volunteers
- 168 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Healthy
Fasting Study of Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg and Corzide® Tablets 80 mg/5 mg
The objective of this study was to investigate the bioequivalence of Mylan's nadolol/bendroflumethiazide 80 mg/5 mg tablets to King's Corzide® 80 mg/5 mg tablets following a single, oral 80 mg/5 mg (1 x 80 mg/5 mg) dose…
- Trial name
- NCT00647660
- Testing
- Nadolol/Bendroflumethiazide Tablets 80 mg/5 mg, Corzide® Tablets 80 mg/5 mg
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid
This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid…
- Trial name
- NCT00961259
- Testing
- Fenofibric Acid 35 mg Tablet, Fenofibric Acid 105 mg Tablet
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetic Study
Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fed Conditions
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each period.
- Trial name
- NCT01714856
- Testing
- Ropinirole hydrochloride CR 2mg Tablets
- Where
- India
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lupin Ltd.
Kidney Diseases, Kidney Injury
A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants
Part I (bioequivalence) will evaluate the bioequivalence of the Oversea Manufactured Sample (used in the MediBeacon Phase 3 Study 100-103; NCT05425719) and Domestic Manufactured Sample in Single Intravenous Dose of MB-102…
- Conditions
- Kidney Diseases, Kidney Injury, Kidney Failure
- Trial name
- NCT05943977
- Testing
- MB-102 DMID, MB-102 OMID, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Where
- 2 sites in China
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Healthy
Bioequivalence Study of Sertraline Hydrochloride 100mg Tablets Under Fed Conditions
The purpose of this study was to evaluate the relative bioavailability of the test formulation of sertraline 100 mg tablets with an already marketed reference formulation Zoloft® 100 mg tablets (Pfizer), under non-fasting…
- Trial name
- NCT00778973
- Testing
- sertraline 100 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Type1 Diabetes Mellitus
A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
Primary Objective: To demonstrate bioequivalence between insulin glulisine given as 300 Units/mL test formulation and insulin glulisine 100 Units/mL reference formulation after a single subcutaneous (SC) dose.
- Trial name
- NCT02910518
- Testing
- Insulin glulisine (U300), Insulin glulisine, Insulin aspart
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- Sanofi
Diabetes, Diabetes Mellitus, Type 2
A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in healthy volunteers.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Trial name
- NCT01916174
- Testing
- insulin degludec/liraglutide
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy Volunteers
A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions (Study 013-10)
The primary objective of this study is to compare the bioavailabilities of a single fixed dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the bioavailabilities of eperisone 50 mg tablets and diclofenac 50…
- Trial name
- NCT01306318
- Testing
- eperisone hydrochloride plus diclofenac sodium capsule, eperisone hydrochloride tablet and diclofenac sodium tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Bioequivalence
A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
A Randomized,Open-label, Single-Dose,Two-Cycle,Cross- Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection Under Advanced Breast Cancers.
- Trial name
- NCT04460820
- Testing
- Doxorubicin Hydrochloride Liposome Injection
- Where
- China
- Volunteers
- 32 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Compare Bioequivalence Patches Previously Used in the NP101-007 Study
Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults
The purpose of this research is to: 1. Compare two study patches having minor differences in patch components 2. Compare the pharmacokinetics (PK - how the body absorbs, metabolizes and eliminates medication) of NP101 (study…
- Trial name
- NCT01381796
- Testing
- NP101, sumatriptan succinate
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- NuPathe Inc.
Pharmacokinetics
Fasting Comparative Bioavailability Study of 2 Meloxicam 15 mg Tablets in Healthy Volunteers Under Fasting Condition
The aim of the study was to compare the bioavailability of two formulations of meloxicam given to healthy volunteers and to demonstrate bioequivalence.
- Trial name
- NCT05125588
- Testing
- Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine), Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Bronchitis
Crossover, Single Dose, Two-stage Bioequivalence Study of SCMC-Lys Salt 1.35 g Powder vs SCMC-Lys Salt 90 mg/mL Syrup
Objectives: The objectives of the study was to investigate the bioequivalence between two formulations containing S-carboxymethyl-L-cysteine L-lysine monohydrate salt (SCMC-lys) when administered as single oral dose in two…
- Trial name
- NCT02858193
- Testing
- SCMC-lys powder 1.35 g, Fluifort® syrup
- Where
- Switzerland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dompé Farmaceutici S.p.A
Healthy
A Study of Two Macitentan Formulations in Healthy Adult Participants
The purpose of this study is to evaluate the bioequivalence of macitentan on the primary pharmacokinetics (PK) parameters between the dispersible final market image (FMI) macitentan tablet and the opsumit tablet in healthy adult…
- Trial name
- NCT05433675
- Testing
- Macitentan
- Where
- Belgium
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Actelion
Healthy
Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition
An open label randomised, two-treatment, two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.
- Trial name
- NCT01052129
- Testing
- Naproxen sodium
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fed Conditions
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Fenofibrate capsules, USP 130 mg manufactured by Ohm Laboratories…
- Trial name
- NCT02306902
- Testing
- fenofibrate, ANTARA® (fenofibrate)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Hyperlipidemia
A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)
The intent of this study is to demonstrate that single doses of the Final Market Image (FMI) ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are bioequivalent to the same doses of ezetimibe…
- Trial name
- NCT01236430
- Testing
- Ezetimibe, Ezetimibe/atorvastatin 10mg/10mg FDC, Atorvastatin 10mg
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Bioequivalence
Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273
The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions.
- Trial name
- NCT06164431
- Testing
- ZSP1273 tablet, zsp1273 granules
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Healthy
Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fed Condition
This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence study.
- Trial name
- NCT01506037
- Testing
- Desloratadine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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