Clinical trials: Therapeutic Equivalency, Healthy
Diabetes Mellitus
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5…
- Trial name
- NCT01192152
- Testing
- saxagliptin, Glucophage XR, saxagliptin + metformin XR (FDC tablet)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants
The purpose of this study is to evaluate the single-dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a…
- Trial name
- NCT02578550
- Testing
- Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide fixed-dose combination (FDC), Emtricitabine/tenofovir alafenamide FDC, Darunavir
- Where
- Netherlands
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Janssen Sciences Ireland UC
Non-valvular Atrial Fibrillation (NVAF)
To Compare the Pharmacokinetics and Safety After a Single Dose Administration of IN-G00002 and IN-R00002 in Healthy Adult Volunteers
To compare the pharmacokinetics and safety after a single dose administration of IN-G00002 and IN-R00002 in healthy adult volunteers
- Trial name
- NCT06725355
- Testing
- IN-R00002, IN-G00002
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Healthy
A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 275 mg Film-coated Tablet in Healthy Adult Volunteers
This is a research study designed to evaluate the rate and extent of absorption of Naproxen from a novel Naproxen sodium tablet and Nalgesin naproxen sodium 275 mg.
- Trial name
- NCT03697889
- Testing
- Naproxen sodium (test product), Naproxen sodium (reference product)
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Infection, Human Immunodeficiency Virus
Evaluation of the Bioequivalence of a Combined Formulated Tablet
Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in phase 3 clinical trials for human immunodeficiency virus (HIV).
- Trial name
- NCT01622790
- Testing
- Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg, Dolutegravir 50 mg, abacavir 600 mg/lamivudine 300 mg
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy Subjects
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233162
- Testing
- Febuxostat-Test product, Febuxostat-Reference product
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Trypanosomiasis, African
Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation
Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of the tablet formulation used in the clinical trials and the final marketed tablet formulation under fed condition.
- Trial name
- NCT02571062
- Testing
- Fexinidazole
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Healthy
Bioequivalence of BIBR 277 Tablet Compared With Capsule in Healthy Male Volunteers
Study to investigate the bioequivalence of BIBR 277 tablet (Erythritol based) vs. BIBR 277 capsule
- Trial name
- NCT02262559
- Testing
- BIBR 277 tablet, BIBR 277 capsule
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetes, Healthy
A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between…
- Trial name
- NCT01766245
- Testing
- semaglutide
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions
The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck \&Co, pepcid 40 mg famotidine tablets under fasting conditions.
- Trial name
- NCT01511731
- Testing
- Famotidine, Pepcid
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
A Study of Marstacimab to Compare Prefilled Pen (PFP) Device to Prefilled Syringe (PFS) Device
The goal in this study is to show that there are not significant differences in biologic activity of the study drug when administered using either the prefilled pen and prefilled syringe.
- Trial name
- NCT04832139
- Testing
- Marstacimab PFP, Marstacimab PFS
- Where
- Belgium
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations
The purpose of this study is to determine whether Transtec(R) PRO 70 µg/h and a new buprenorphine patch formulation lead to same plasma levels of buprenorphine after multiple dose application.
- Trial name
- NCT00387777
- Testing
- Patch with centrally acting analgesic, Transtec(R) PRO (buprenorphine)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Healthy
Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation
- Trial name
- NCT04486157
- Testing
- IN-A012, Akynzeo 300Mg-0.5Mg Capsule
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Healthy
Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects
The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition with water in Healthy Japanese Subjects
- Trial name
- NCT01699724
- Testing
- JZoloft, sertraline ODT
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Urologic Diseases
Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
The purpose of this study is to assess the bioequivalence of the second generation dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available commercial combination of dutasteride 0.5 milligram…
- Trial name
- NCT02052713
- Testing
- Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg, Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule
- Where
- United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers
The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet following a 400 to 500 calorie, 600 to 750 calorie, or 800 to 1000 calorie medium-fat lunch as…
- Trial name
- NCT01270815
- Testing
- Pregabalin controlled release, 330 mg, 400 to 500 calories, Pregabalin controlled release, 330 mg, 600 to 750 calories, Pregabalin controlled release, 330 mg, 800 to 1000 calories
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Type 2 Diabetes Mellitus
Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.
- Trial name
- NCT00944450
- Testing
- Sitagliptin phosphate anhydrous formulation, Comparator: sitagliptin phosphate monohydrate form
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Epilepsy, Tonic-Clonic
Topiramate Bioequivalence Study Brazil - Fast
This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the…
- Trial name
- NCT01439438
- Testing
- Topiramate coated tablet, Topamax® coated tablet
- Where
- Brazil
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions
The objective of this study was to compare the rate of absorption and the oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc.
- Trial name
- NCT00829790
- Testing
- Doxycycline Monohydrate
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers
Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects
The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in…
- Trial name
- NCT01394224
- Testing
- Levetiracetam
- Where
- United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
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