Clinical trials: Therapeutic Equivalency
Diabetes, Diabetes Mellitus, Type 2
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects
This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.
- Trial name
- NCT01527630
- Testing
- biphasic insulin aspart 50
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions
The objective of this study was to assess the single-dose bioequivalence of KUDCO's and Wyeth Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed conditions.
- Trial name
- NCT01179659
- Testing
- Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
- Where
- Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Kremers Urban Development Company
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
Solid Tumor Cancer
Bioequivalence Study of Trifluridine and Tipiracil Hydrochloride Tablets on Fasting and Fed in Humans
The test formulation of Trifluridine and Tipiracil Tablets (20 mg) is bioequivalent to the reference formulation (Lonsurf®) in Chinese patients with solid tumors under fed and fasting conditions.
- Trial name
- NCT07492173
- Testing
- Trifluridine and Tipiracil Tablets, Lonsurf®
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
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
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.
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.
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