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
Healthy
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd.
- Trial name
- NCT01149473
- Testing
- Losartan potassium/Hydrochlorothiazide
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting
This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals…
- Trial name
- NCT00834197
- Testing
- Mirtazapine 15 mg (Orally Disintegrating) Tablets, REMERON SolTab® 15 mg Orally Disintegrating Tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers
A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants
The study involves 4 injections of insulin lispro and its purpose is to: Determine if 2 formulations of insulin lispro are treated by the body in a similar way.
- Trial name
- NCT02111083
- Testing
- Insulin Lispro
- Where
- Singapore
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Chemotherapy-Induced Nausea and Vomiting
A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)
This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on the bioavailability of oral aprepitant.
- Trial name
- NCT00945321
- Testing
- aprepitant 165 mg, Comparator: aprepitant 185 mg, Comparator: fosaprepitant 150 mg
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Prostatic Hyperplasia
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin
It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions receive, in each period, the test formulation…
- Trial name
- NCT01262989
- Testing
- Test formulation, Reference formulation
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.
The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in…
- Trial name
- NCT01947153
- Testing
- Metformin, Linagliptin
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Anaemia
Daprodustat Bioequivalence and Food Effect Study
This is two-way crossover study to compare pharmacokinetic (PK) of daprodustat 2 milligram (mg) versus 4 mg tablets and food effect on the PK of daprodustat following single oral doses in healthy Japanese male subjects.
- Trial name
- NCT03493386
- Testing
- Daprodustat 2 mg tablet, Daprodustat 4 mg tablet
- Where
- Japan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-release tablets ( manufactured by TEVA Pharmaceuticals Industries, Ltd.
- Trial name
- NCT00835588
- Testing
- Pantoprazole Sodium 40 mg delayed-release tablets, PROTONIX® 40 mg delayed-release tablets.
- Where
- 2 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Hypertension
Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)
This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.
- Trial name
- NCT00953680
- Testing
- losartan potassium (+) hydrochlorothiazide (HCTZ), losartan potassium, hydrochlorothiazide (HCTZ)
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Healthy
Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
The Purpose of this study os to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under post-prandial…
- Trial name
- NCT00833664
- Testing
- Terbinafine HCl 250mg tablets, Lamisil® 250 mg Tablets
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline…
- Trial name
- NCT01235195
- Testing
- sertraline hydrochloride
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bioequivalence, Fixed Dose Combination Tablets
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects
This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions
- Conditions
- Bioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
- Trial name
- NCT02637037
- Testing
- dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao), dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd.
- Trial name
- NCT01149486
- Testing
- Losartan potassium/Hydrochlorothiazide, Hyzaar®
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Glimepiride 4 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of glimepiride 4 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT00835172
- Testing
- Glimepiride 4 mg Tablets, AMARYL® 4 mg Tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions
The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation…
- Trial name
- NCT00830219
- Testing
- Ropinirole HCl 0.25 mg Tablets, Requip® 0.25 mg Tablets
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Lamotrigine 25 mg Chewable Tablets, Non-Fasting
The objective of this study is to compare the rate and extent of absorption of lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg chewable dispersible tablets under fed…
- Trial name
- NCT00838136
- Testing
- Lamotrigine 25 mg Chewable Tablets, Lamictal® 25 mg Chewable Tablets
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.
- Trial name
- NCT02028767
- Testing
- Empagliflozin 2.5 mg, Empagliflozin 10 mg, Metformin 500 mg
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.
- Trial name
- NCT01099709
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP