Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with Depakote® Sprinkle125 mg capsules in…
- Trial name
- NCT01132183
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Respiratory Disorders, Asthma and Rhinitis
Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions
This study is conducted to determine whether the test product (GW483100 10 mg containing montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference montelukast sodium 10 mg tablets (innovator…
- Trial name
- NCT02658422
- Testing
- Test Montelukast, Reference Montelukast
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Study to Determine the Fasting 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 fasted state.
- Trial name
- NCT01100086
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Myeloma Multiple
Bioequivalence Studies of Dasatinib 100 Mg
A bioequivalence study of Dasatinib will be carried out in 46 healthy subjects, in fed condition, following the complete replicated design, randomized, comparative of 2 sequences, 2 study formulations, in a single dose of 100 mg…
- Trial name
- BE-Dasatinib (NCT05944783)
- Testing
- Dasatinib 100 MG
- Where
- Colombia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
Healthy
Fasting Study of Metolazone Tablets 5 mg and Zaroloxyn® Tablets 5 mg
The objective of this study was to investigate the bioequivalence of Mylan metolazone 5 mg tablets to Celltech Zaroxolyn® 5 mg tablets following a single, oral 10 mg (2 x 5 mg) dose administration under fasting conditions.
- Trial name
- NCT00649181
- Testing
- Metolazone Tablets 5 mg, Zaroloxyn® Tablets 5 mg
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence of Two Azilsartan Formulations
Bioequivalence Study of Azilsartan Tablets in Chinese Healthy Volunteers
The purpose of this study was to determine the bioequivalence of two azilsartan formulations after administration of single doses to healthy subjects under fasted and fed conditions.
- Trial name
- NCT03652792
- Testing
- Azilsartan (Zhaoke), Azilsartan (Takeda)
- Where
- Hong Kong
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Lee's Pharmaceutical Limited
Healthy
A Relative Bioavailability Study of 50 mg Venlafaxine Hydrochloride Tablets Under Fed Conditions
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf 50 mg venlafaxine hydrochloride tablets with Wyeth Pharmaceuticals (Effexor®) 50 mg venlafaxine (as venlafaxine hydrochloride)…
- Trial name
- NCT00871364
- Testing
- VENLAFAXINE TABLETS 50 mg , single dose, Effexor® Tablets equivalent to 50 mg venlafaxine
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Bioequivalence
Bioequivalence Study of Sulfadoxine/ Pyrimethamine Dispersible Tablets in Healthy Subjects Under Fasting Conditions
To asses bio equivalence between two (500 mg sulfadoxine / 25 mg pyrimethamine) formulation
- Trial name
- NCT05497063
- Testing
- Sulfadoxine/Pyrimethamine dispersible tablets, 250 mg sulfadoxine / 12.5 mg pyrimethamine & 500 mg sulfadoxine / 25 mg pyrimethamine, G-COSPE® tablets
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Emzor Pharmaceutical Industries Limited
Healthy Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers Under Fed Condition.
This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fed conditions.
- Trial name
- NCT07267221
- Testing
- DWJ1622, DWC202313, DWC202314
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy Volunteer, Dabigatran
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of…
- Conditions
- Healthy Volunteer, Dabigatran, Bioequivalence Study
- Trial name
- NCT06441916
- Testing
- Dabigatran Etexilate Capsules 150 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy
Bioequivalence Study of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland).
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules…
- Trial name
- NCT04657744
- Testing
- Sphingomod, Gilenya
- Where
- Egypt
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to 1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl tablets of Dr.
- Trial name
- NCT01136525
- Testing
- Valacyclovir Hydrochloride
- Where
- India
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition
To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil®PM, of Wyeth consumer health care, USA, in normal, healthy…
- Trial name
- NCT01053338
- Testing
- Ibuprofen and Diphenhydramine Citrate
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Fasting State
Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01578252
- Testing
- Ondansetron Tablets USP 8 mg, Ondansetron Hydrochloride
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Fed Conditions
Bioequivalence Study to Compare Metformin / Vildagliptin (850 mg/50 mg) Versus Galvumet®
The aim of this study is to assess bioequivalence between a single oral dose from the test product Metformin / Vildagliptin tablets (850 mg as metformin hydrochloride / 50 mg as vildagliptin) manufactured by SAIPH versus the…
- Trial name
- NCT06103747
- Testing
- Metformin / Vildagliptin Film Coated Tablets (850 mg / 50 mg), Galvumet® Film Coated Tablets (850 mg / 50 mg)
- Where
- Tunisia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Reseach Laboratory of Clinical and Experimental Pharmacology
Healthy
A Relative Bioavailability Study of Citalopram HBr 10 mg Tablets Under Fasting Conditions
The purpose of this study is compare the relative bioavailability of 10 mg Citalopram Hydrobromide tablets by Purepac Pharmaceutical Co with that of 10 mg CELEXATM tablets distributed and marketed by Forest Pharmaceuticals, Inc.
- Trial name
- NCT00865943
- Testing
- Citalopram HBr eq. 10 mg tablets, single dose, CELEXATM 10 mg tablets, single dose
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Primary Hypercholesterolaemia
A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228B in healthy subjects.
- Trial name
- NCT06884098
- Testing
- AD-228B, AD-2284
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Healthy
A Bioequivalence Study of Domestic (Made in China) and Imported Mizolastine Tablets in Healthy Volunteers
The purpose of the study is to evaluate the bioequivalence (the way in which different forms of the same drug are absorbed in the body) of single-dose administration of domestic (made in China) mizolastine tablets and imported…
- Trial name
- NCT01928316
- Testing
- Mizolastine domestic (made in China), Mizolastine (imported)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
Healthy Men and Women
Open-label Study Using 50 Mg Liquid Etanercept Subcutaneous Injection in the Thigh to Compare an Auto-injector Device and a Manual Injection in Healthy Subjects
A single-center, open-label, randomized study with a screening period of up to 21 days. Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in the thigh to compare injection by auto-injection…
- Trial name
- NCT02588534
- Testing
- etanercept (ENBREL®) via auto-injector device, Etanercept (ENBREL®) via Manual injection
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy
Bioequivalence of Two Formulations of Esomeprazole
Bioequivalence of Two Formulations of Esomeprazole 40mg
- Trial name
- NCT02543606
- Testing
- Esomelone, Nexium
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
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