Clinical trials: Therapeutic Equivalency
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
Cancer, Ovarian Cancer
Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade…
- Trial name
- NCT07371104
- Testing
- DWZ2501 (Olaparib 150mg), DWC202510 (Olaparib 150mg)
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
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
Otitis Externa
A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par Pharmaceutical Companies, Inc.) to the already-marketed…
- Trial name
- NCT01910155
- Testing
- Ciprofloxacin/Dexamethasone, Ciprodex (R)
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 455 people
- Sponsor
- Par Pharmaceutical, Inc.
Asthma
Clinical Endpoint Bioequivalence Study for Fluticasone Propionate and Salmeterol Xinafoate
A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 µg and Salmeterol Xinafoate 50 µg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects…
- Trial name
- NCT02649478
- Testing
- Fluticasone / Salmeterol, Advair Diskus 100/50
- Where
- 100 sites in United States
- Volunteers
- 1,430 people
- Sponsor
- Roxane Laboratories
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.
Schizophrenia
Bioequivalence Study to Compare Brexpiprazole 4 mg Film Coated Tablets Versus RXULTI 4 mg Film Coated Tablet (Brexpiprazole)
Single dose oral bioequivalence study of Brexpiprazole 4 mg Film Coated Tablets and RXULTI® (Brexpiprazole) 4 mg film-coated tablets in healthy adult human subjects under fasting conditions.
- Trial name
- NCT07266792
- Testing
- Brexpiprazole Film Coated Tablets, RXULTI film coated tablet
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Patient Participation
Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer
A multicenter, randomized, open-label, three-period, and reference-replicated crossover study was conducted in 48 patients with colorectal or breast cancer under fed conditions to assess the bioequivalence between two…
- Trial name
- NCT04420871
- Testing
- 150 mg of Xeloda®, 150 mg of capecitabine
- Where
- China
- Volunteers
- 48 people
- Sponsor
- The Affiliated Hospital of Qingdao University
Infections, Respiratory Tract
Bioequivalence Study of Cephalexin Suspension 250
The objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent. Test product was Ceporex® (250 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5…
- Trial name
- NCT01767571
- Testing
- Cephalexin 125 mg/5ml, Cephalexin 250mg/5ml
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus
The Study Aims to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safeyt Profile of Test Product Compared to Reference Product Will be Assessed.
To evaluate and compare the relative bioavailability and therefore the bioequivalence of Vildagliptin Tablets 50 mg of AET Laboratories Private Limited, India, with GALVUS® 50 mg Tablets of Novartis Europharm Limited, United…
- Trial name
- NCT05329844
- Testing
- Vildagliptin 50 MG
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- AET Laboratories Private Limited
Healthy Participants
Bioequivalence Study for Crizotinib Encapsulated Microsphere Formulation (eMS)
Bioequivalence study to evaluate the pharmacokinetics of a new crizotinib encapsulated microsphere (eMS) formulation
- Trial name
- NCT04856293
- Testing
- Crizotinib
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
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