Clinical trials: Therapeutic Equivalency
Healthy
Clarithromycin 500 mg Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Clarithromycin Tablets with that of 500 mg BIAXIN® Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects…
- Trial name
- NCT00835692
- Testing
- Clarithromycin, Biaxin®
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
Diabetes Mellitus, Type 2
An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin, 10 mg + 1000 mg Versus the Combined Use of Forxiga™, 10 mg and Two Glucophage® Long, ER Tablets, 500 mg Co-administered to Healthy Volunteers Under Standard Fed Conditions
The aim of this study is to demonstrate bioequivalence of fixed dose combination Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg, (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin)…
- Trial name
- NCT02722239
- Testing
- Xigduo XR, Metformin ER (Glucophage® long), Dapagliflozin (Forxiga)
- Where
- Russia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Fasting
Bioequivalence Study of Risperidone Tablet 1 mg Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01722201
- Testing
- Risperidone Tablet 1 mg, Risperidone
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Diabetes Mellitus, Type 2
OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.
This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under…
- Trial name
- NCT01842620
- Testing
- Metformin
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
A Relative Bioavailability Study of Gabapentin Tablets 800 mg Under Fasting Conditions
The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 800 mg NEURONTIN® Tablets by Parke-Davis following a single oral dose (1 x 800 mg) in…
- Trial name
- NCT00865423
- Testing
- Gabapentin 800 mg Tablets, single dose, NEURONTIN® 800 mg Tablets, single dose
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fed Conditions
The purpose of this study is to determine the pharmacokinetics and bioequivalence of Risperidone formulations after administration of single doses to normal, healthy subjects under fed conditions.
- Trial name
- NCT01222923
- Testing
- Risperidone
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System
The objective of this study was primarily to investigate the bioequivalence and secondly to assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system with and without an overlay system following…
- Trial name
- NCT00647842
- Testing
- Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay, Fentanyl Transdermal System 25 mcg/h
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Type 2 Diabetes
BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin extended release (XR) fixed dose combination (FDC) tablet relative to 5 mg Onglyza™ and 500…
- Trial name
- NCT01305551
- Testing
- Saxagliptin, Metformin XR, Saxagliptin/Metformin XR FDC
- Where
- Brazil
- Volunteers
- healthy volunteers welcome
- Sponsor
- AstraZeneca
Alzheimer Disease
Study Comparing Lecozotan SR Two 5-mg Tablets Vs. Lecozotan SR One 10-mg Tablet in Healthy Subjects
To determine the bioequivalence between two 5-mg tablets of lecozotan and the new 10-mg tablet of lecozotan.
- Trial name
- NCT00494962
- Testing
- lecozotan SR
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
Fasting Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan quinapril hydrochloride 40 mg tablets compared to Parke-Davis Accupril® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose under fasting…
- Trial name
- NCT00649103
- Testing
- Quinapril Hydrochloride Tablets 40 mg, Accupril® Tablets 40 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Non- Fasting Conditions
The purpose of this study is to compare experimental evaluation of relative bioavailabilities in healthy, human subjects under non-fasting conditions.
- Trial name
- NCT01161927
- Testing
- Nizatidine, Axid
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation
This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.
- Trial name
- NCT01285505
- Testing
- alprazolam commercial sublingual formulation, alprazolam test sublingual tablet
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Asthma, COPD
Bioequivalence Study to Assess Systemic Exposure of FP and SAL FDC From Different DPIs
This is a crossover study to assess the systemic pharmacokinetics of fluticasone propionate (FP) and salmeterol (SAL). Study medication will be administered as fixed dose combinations (250 µg FP and 50 µg SAL) from the Advair®…
- Trial name
- NCT02215122
- Testing
- MGR001, Advair® Diskus®, Seretide™ Accuhaler™
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Mylan Pharma UK Ltd.
Healthy
Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg
The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fed…
- Trial name
- NCT00649480
- Testing
- BALSALAZIDE DISODIUM CAPSULES, 750 MG, COLAZAL® Capsules 750 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Diabetes Mellitus Type 2
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)
Empagliflozin and metformin hydrochloride are two separate drugs. The combination of these two drugs in one tablet are used for the treatment of type 2 diabetes, along with diet and exercise, and can be used with other drugs, if…
- Trial name
- NCT06823856
- Testing
- Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated tablets, Synjardy 12.5 mg/1000 mg film-coated tablets
- Where
- Russia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Gedeon Richter Plc.
Healthy
Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of risperidone 1 mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablets under fed conditions.
- Trial name
- NCT00829894
- Testing
- Risperidone
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Psoriasis
Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults
BFI-751 is being developed by BioFactura Australia Pty Ltd as a biosimilar drug to Stelara® (EU licenced and US licenced) (ustekinumab) is a prescription biologic medicine used to treat people with Crohn's disease, Ulcerative…
- Trial name
- NCT04843631
- Testing
- BFI-751, EU-STELARA®, US-STELARA®
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- BioFactura Australia Pty Ltd.
Healthy
Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg
The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10mg/20mg)…
- Trial name
- NCT00649519
- Testing
- Amlodipine and Benazepril HCl Capsules 10 mg/20 mg, Lotrel® Capsules 10 mg/20 mg
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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