Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Two Way Bioequivalence Study Under Fed Conditions
The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions.
- Trial name
- NCT01217801
- Testing
- Ondansetron (ODFS), Ondansetron (ODT)
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- MonoSol Rx
Healthy
A Bioequivalence Study of Levetiracetam Versus Keppra
The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.
- Trial name
- NCT00926302
- Testing
- Levetiracetam (Lotus Pharmaceutical Co.,Ltd.), Keppra (Levetiracetam - USB SA Pharma Sector)
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Tri-Service General Hospital (TSGH)
Major Depressive Disorder, Obsessive-Compulsive Disorder
Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers
The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 20 mg tablets (test) and Paxil® (reference) administered as 20 mg tablet under fed conditions.
- Conditions
- Major Depressive Disorder, Obsessive-Compulsive Disorder, Panic Disorder, Social Anxiety Disorder
- Trial name
- NCT03504475
- Testing
- Paroxetine Hydrochloride Tablet 20 mg, Paxil® 20 mg
- Where
- 2 sites in China
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Beijing Tongren Hospital
Healthy
A Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared With Clarityne Tablets
The purpose of this study is to assess the bioequivalence of Xisimin (loratadine) compared with Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under fasting condition as part of Cohort 1 and under…
- Trial name
- NCT03196531
- Testing
- Loratadine (Xisimin [Test Treatment]), Loratadine (Clarityne [Reference Treatment])
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
Healthy
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting Conditions
This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT02322645
- Testing
- Eszopiclone Tablets 3 mg
- Where
- India
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
Bioequivalence of Two Lispro Formulations
This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.
- Trial name
- NCT01133392
- Testing
- Insulin lispro A, Insulin lispro B
- Where
- Singapore
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet
The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a pregabalin controlled release tablet with and without coadministration of erythromycin and 2) evaluate the safety and tolerability of a…
- Trial name
- NCT01342198
- Testing
- Pregabalin controlled release, 330 mg, erythromycin
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Chinese Healthy Volunteers
A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers
This study compares the pharmacokinetics characteristics of a single oral intake of an imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang Tai)(1*250mg/tablet) in healthy male volunteers to…
- Trial name
- NCT02196805
- Testing
- Group A: imported Probucol ( Lorelco), Group B: Marketed Probucol ( Chang Tai)
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Otsuka Beijing Research Institute
Cardiovascular Disease
Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects
Clopidogrel is a potent anti-thrombotic drug that inhibits adenosine diphosphate (ADP)-induced platelet aggregation. This is an open-label, randomized, single dose, three-way cross over, six sequence study to investigate the…
- Trial name
- NCT02502812
- Testing
- Clop F1, Clop F2, Innovator
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Benign Prostatic Hyperplasia
Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers After Meal
This study is an open-label, randomized, fed, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc.
- Trial name
- NCT03887871
- Testing
- Harnal-D Tab., Chong Kun Dang Tamsulosin HCl Tab.
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy Volunteers
A Study of Cephalexin Liquid for Pediatrics in Healthy Adults Participants
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods.
- Trial name
- NCT02123472
- Testing
- Cephalexin
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer
The primary purpose of this study is to demonstrate the equivalence of budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with a spacer to BGF MDI hydrofluoroalkane (HFA) with a…
- Trial name
- NCT06340581
- Testing
- Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO, Treatment C: BGF MDI HFO
- Volunteers
- healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioequivalence
Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions
A single center, open label, randomized, single-dose, two period, Two way cross-over study to explore the Bioequivalence of Test Product Xaroban (Rivaroxaban) 20 mg Tablet with the reference product Xarelto (Rivaroxaban) 20 mg…
- Trial name
- Bioequivalence (NCT04689919)
- Testing
- Rivaroxaban 20 MG Oral Tablet
- Where
- Pakistan
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Karachi
Healthy Volunteers
Bioequivalence Study of Prednisolone and Dexamethasone
The purpose of this study is to compare two different glucocorticoids, prednisolone and dexamethasone at two different doses for their organ specific effects, utilizing modern day standards.
- Trial name
- CORE (NCT04733144)
- Testing
- Prednisolone, Dexamethasone
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
Healthy
A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants
A Phase 1 trial to investigate bioequivalence between 5 × 10 mg tablets and 2 × 25 mg tablets of daridorexant in healthy male and female Japanese participants
- Trial name
- NCT05877222
- Testing
- Daridorexant 10 mg, Daridorexant 25 mg
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Pain
Bioequivalence and Adhesion Comparison of Buprenorphine Patches
To compare a 2nd generation Buprenorphine Transdermal System (BTDS) patch with a marketed 1st generation BTDS patch to confirm that the two are bioequivalent (deliver the same amount of drug) and that they equally both stick to…
- Trial name
- NCT02268422
- Testing
- Buprenorphine
- Where
- 2 sites in United Kingdom
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Mundipharma Research Limited
Healthy Volunteer
A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers
This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period cross-over study will compare the bioequivalence of three test RO5424802 capsule formulations with the reference capsule formulation in healthy…
- Trial name
- NCT02074553
- Testing
- Ro542-4802/F03 (Reference), Ro542-4802/F07 (Test), Ro542-4802/F08 (Test)
- Where
- United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 300 μg tablets to Lloyd's Levothroid® 300 μg tablets following a single 600 μg (2 x 300 μg) dose administered in healthy adult…
- Trial name
- NCT00648700
- Testing
- Levothyroxine Sodium Tablets 300 μg, Levothroid® Tablets 300 μg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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
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