Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)
The study will assess the bioequivalence between single doses of GXR manufactured in Merck Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug) under fed and fasted state in healthy…
- Trial name
- NCT03566810
- Testing
- Test GXR, Reference GXR
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Bioequivalence, AUC, Cmax, Pharmacokinetics
Prilosec Bioequivalence Study in Healthy Volunteers
This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose Bioequivalence Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules Manufactured by AstraZeneca with Omeprazole 20 and 40-mg…
- Trial name
- NCT01921920
- Testing
- Omeprazole
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalence Study of Fenofibrate 160mg Tablets Under Fed Conditions
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Abbott (TriCor) 160 mg fenofibrate tablets under fed conditions.
- Trial name
- NCT00775359
- Testing
- Fenofibrate 160 mg tablets
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence of the New Formulation of WAL 801 CL Dry Syrup Compared to the Conventional Formulation of WAL 801 CL Dry Syrup in Healthy Male Volunteers
To establish the bioequivalence of the new formulation of WAL 801 CL dry syrup vs. the conventional formulation of WAL 801 CL dry syrup
- Trial name
- NCT02260050
- Testing
- WAL 801 CL dry syrup new formulation, WAL 801 CL dry syrup conventional formulation
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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.
Healthy Participants
A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
- Trial name
- NCT05362045
- Testing
- Mavacamten
- Where
- 4 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
Bioequivalence Study of Amlodipine Tablets Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption of Ranbaxy amlodipine 10 mg tablet to that of Norvasc® 10 mg tablet after a single, one4ablet dose in fasted subjects.
- Trial name
- NCT00775905
- Testing
- amlodipine 10 mg tablet
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Type 2 Diabetes Mellitus
Sotagliflozin Bioequivalence Study
Primary Objective: To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and…
- Trial name
- NCT03211195
- Testing
- Sotagliflozin (SAR439954)
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy Adult Subjects
Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects
This is a Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting…
- Trial name
- NCT06107205
- Testing
- TTYP01, Radicava, Radicava ORS
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Shanghai Auzone Biological Technology Co., Ltd.
Healthy
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) Taken With Water in Healthy Adult Males
The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in healthy adult male subjects.
- Trial name
- NCT02218645
- Testing
- WE 941 OD tablets, Brotizolam
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Type 2 Diabetes Mellitus
To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered Separately
This is an open-label, randomised study to compare the similarity of a combination Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and fed conditions in healthy volunteers.
- Trial name
- NCT01535677
- Testing
- Dapagliflozin + Glucophage tablet fasted, Dapagliflozin/metformin IR FDC tablet fasted, Dapagliflozin + Glucophage tablet fed
- Where
- United Kingdom
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Fasting Study of Alprazolam Extended-Release Tablets 1 mg to Xanax XR Tablets 1 mg
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 1 mg Extended-release tablets to Pharmacia \& Upjohn's Xanax XR 1 mg tablets following a single, oral 3 mg (3 x 1 mg) dose administered under…
- Trial name
- NCT00647894
- Testing
- Alprazolam Extended-Release Tablets 1 mg, Xanax XR Tablets 1 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Men and Women
Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)
To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen…
- Trial name
- NCT02179931
- Testing
- Flupentixol/melitracen film-coated tablet, Flupentixol/melitracen coated tablet (Deanxit®)
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Anti-Infective Agents
Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules
A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods.
- Trial name
- NCT01073553
- Testing
- Cephalexin capsules (Optocef, BAYO5448 ), Cephalexin capsules (Keflex)
- Where
- Mexico
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants
The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet coadministered with canagliflozin in healthy…
- Trial name
- NCT02865668
- Testing
- Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Canagliflozin, Metformin Extended Release (XR)
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Bioequivalence Study of Torrent Pharmaceutical Limited's Venlafaxine Hydrochloride ER Capsules Under Fed Conditions
Objective: The Bioequivalence studies were performed to compare the rate and extent of release of the drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride Extended-Release Capsules 150mg of…
- Trial name
- NCT01418625
- Testing
- Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test formulation, Torrent Pharmaceutical Limited., India)
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.
Mexican healthy volunteers will receive the current form of the drug (under the name of Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.
- Trial name
- NCT01122940
- Testing
- Epamin: Reference Drug, Phenytoin: Study Drug
- Where
- Mexico
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Bioequivalence of Telmisartan as Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination Tablet or as Two Telmisartan 40 mg Tablets in Healthy Male Volunteers
To establish bioequivalence of telmisartan orally administrated in two different ways: either with a telmisartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg fixed-dose combination tablet or with two telmisartan 40 mg tablets
- Trial name
- NCT02276391
- Testing
- Telmisartan/HCTZ combination, Telmisartan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Menopause, Healthy
Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women
This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA)…
- Trial name
- NCT01596010
- Testing
- 2 mg estradiol / 1 mg norethisterone acetate (NETA)
- Where
- Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Bioequivalence
Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition
The current study is conducted to evaluate and compare the relative bioavailability for Esomeprazole in two different products containing 40 mg Esomeprazole after a single oral dose administration under fasting conditions.
- Trial name
- NCT05235217
- Testing
- Test product (T) 40 mg Hard Gelatin Capsules, Reference product (R) 40 mg Hard Gelatin Capsules
- Where
- Egypt
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Future University in Egypt
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