Clinical trials: Therapeutic Equivalency
Healthy
Meloxicam 15 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of meloxicam from a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under fed conditions.
- Trial name
- NCT00840879
- Testing
- Meloxicam 15 mg Tablets, Mobic® 15 mg Tablets
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg
The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose…
- Trial name
- NCT00649870
- Testing
- Valacyclovir Hydrochloride Tablets 1000 mg, Valtrex® Tablets 1000 mg
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.
- Trial name
- NCT02617758
- Testing
- Fentanyl
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Epilepsy (treatment Refractory)
Bioequivalence Study of Two Brivaracetam Oral Solutions in Healthy Adults Under Fasting and High-Fat Meal Conditions
The goal of this clinical trial is to evaluate the bioequivalence of Brivaracetam oral solution under fasting and high-fat meal conditions in healthy adults.
- Trial name
- BE (NCT06762743)
- Testing
- Brivaracetam Oral Solution (Test Formulation), Brivaracetam Oral Solution (Reference Formulation)
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Healthy
Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study
The purpose of this study is to assess bioequivalence between metformin hydrochloride (Glucophage® XR) manufactured in PT Merck Tbk, Indonesia (test drug) and metformin hydrochloride (Glucophage® XR) manufactured in Merck Santé…
- Trial name
- NCT03583385
- Testing
- Glucophage XR (Test drug), Glucophage XR (Comparator drug)
- Where
- Indonesia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Secondarily Infected Traumatic Skin Lesions
A Study to Evaluate the Safety and Bioequivalence of Mupirocin Calcium Cream, 2% and Bactroban® Cream and Compare Both to a Vehicle in Treatment of Secondarily Infected Traumatic Skin Lesions.
The primary objective of this study is to determine the comparability of the safety and efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily infected traumatic skin lesions.
- Trial name
- NCT01876550
- Testing
- Mupirocin Calcium Cream, 2%, Bactroban® Cream, Cream vehicle of test product
- Volunteers
- 1,902 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Healthy
A Study of Baricitinib in Healthy Participants
The purposes of this study are to determine: If there are any differences in the amount of baricitinib in the blood/body when taken in two different forms.
- Trial name
- NCT03212638
- Testing
- Baricitinib suspension, Baricitinib tablet
- Where
- Singapore
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Bioequivalence Study of Simvastatin Tablets, 80 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co.
- Trial name
- NCT01167933
- Testing
- Simvastatin
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Hypertension
Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - A
The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.
- Trial name
- NCT02801526
- Testing
- CKD-330 16/5mg - A, Candesartan 16mg and Amlodipine 5mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy
Bioequivalence Study of Topiramate Tablets 25mg Under Fasting Conditions
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Ortho-McNeil Pharmaceutical (Topamax®) 25 mg topiramate tablets following a 50 mg dose under fasting conditions.
- Trial name
- NCT00901784
- Testing
- Topiramate
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Diffuse Large B-Cell Lymphoma
MabionCD20 Compared to MabThera in Lymphoma Patients
The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20 (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients with CD20-positive diffuse large B-cell…
- Trial name
- MADILYM (NCT02617485)
- Testing
- Rituximab, Doxorubicin, Vincristine
- Where
- 35 sites in Bosnia and Herzegovina, Croatia and 5 more
- Volunteers
- 143 people
- Sponsor
- Mabion SA
Achondroplasia
Bioequivalence Study to Compare Two Injection Devices for BMN 111 in Healthy Participants
The purpose of this study is to establish the bioequivalence of a single SC dose of BMN 111 administered using a vial and syringe versus using an injector pen.
- Trial name
- NCT05813314
- Testing
- BMN 111 administration via Injector Pen, BMN 111 administration via vial and syringe
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- BioMarin Pharmaceutical
Healthy
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fasting Conditions
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended release tablets USP 10 mg (containing felodipine…
- Trial name
- NCT02327247
- Testing
- Felodipine, PLENDIL®
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Volunteers
Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.
- Trial name
- NCT01632449
- Testing
- Test product, Reference product
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Biogen
Pain
A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments
This study is designed to assess bioequivalence between one test and two reference formulations used for treatment of headaches and temporary relief of pain.
- Trial name
- NCT01316978
- Testing
- Ibuprofen
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Bronchial Asthma
BE Study of Fluticasone Propionate/Salmeterol Inhalation Powder in Asthma Patients
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patients with asthma.
- Trial name
- NCT03394989
- Testing
- Fluticasone propionate/salmeterol 100/50 µg, Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT
- Where
- United States
- Volunteers
- 1,366 people
- Sponsor
- Cipla Ltd.
Fasting
Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting Conditions
To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation (Plavix® 300 mg tablets) in healthy, adult…
- Trial name
- NCT01621750
- Testing
- Clopidogrel
- Where
- India
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Schizophrenia, Bipolar I Disorder
Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions
Study to compare the pharmacokinetics and pharmacodynamics of VHX-896 and iloperidone and evaluate the safety and tolerability of VHX-896 and iloperidone in patients with schizophrenia or bipolar I disorder under steady state…
- Trial name
- NCT06494397
- Testing
- VHX-896 and iloperidone, Iloperidone and VHX-896
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- Vanda Pharmaceuticals
Acute Myeloid Leukemia
Extension Study, Pilot, Compassionate Use of Azacitidine 300 mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients
Extension study, pilot, single-arm, compassionate use of Hikma Azacitidine 300 mg Film coated tablets test product for the Acute Myeloid Leukaemia (AML) patients who completed Hikma bioequivalence study with protocol number…
- Trial name
- NCT06572982
- Testing
- Azacitidine
- Where
- United Arab Emirates
- Volunteers
- 20 people
- Sponsor
- Hikma Pharmaceuticals LLC
Healthy Subject
A Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers
This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different…
- Trial name
- NCT05318820
- Testing
- HMPL-523
- Where
- China
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Hutchison Medipharma Limited
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