Clinical trials: Therapeutic Equivalency
Healthy
Fasting Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride Extended-release tablets to ALZA's Ditropan XL® tablets following a single, oral 20 mg (4 x 5 mg) dose under…
- Trial name
- NCT00650481
- Testing
- Oxybutynin Chloride Extended-release Tablets 5 mg, Ditropan XL® Tablets 5 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
FED
Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Non-Fasting Conditions
To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under…
- Trial name
- NCT01283867
- Testing
- Mycophenolate Mofetil
- Where
- India
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Hyperlipidemia
A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)
The intent of this study is to demonstrate that single doses of the Final Market Image (FMI) ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are bioequivalent to the same doses of ezetimibe…
- Trial name
- NCT01236430
- Testing
- Ezetimibe, Ezetimibe/atorvastatin 10mg/10mg FDC, Atorvastatin 10mg
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Clinical Pharmacology
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult Subjects
To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U.
- Trial name
- NCT03517930
- Testing
- Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG), Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Bayer
Drug Use
Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject
The objective of this present study was to investigate whether Glufor® 500 (metformin hydrochloride 500 mg) film-coated tablets manufactured by PT.
- Trial name
- NCT05753371
- Testing
- Metformin Hydrochloride 500 MG
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PT. Pyridam Farma Tbk
Healthy
Bioequivalence Study of Torrent Pharmaceutical Limited's ISMN 120 mg ER Tablets Under Fasting Condition
Objective: to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA.
- Trial name
- NCT01418534
- Testing
- Torrent's Isosorbide Mononitrate 120 mg ER Tablets
- Where
- 2 sites in India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy Volunteers
A Study of Evacetrapib in Healthy Japanese Participants
The purpose of this study is to determine if two different dosing strategies for evacetrapib will have essentially the same effect on the body.
- Trial name
- NCT02226653
- Testing
- Evacetrapib
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Peripheral (Sensorimotor) Diabetic Polyneuropathy
To Assess the Bioequivalence of Test Oral Formulation of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Ilko Ilac San. Ve Tic. A.S. Versus Reference Thioctacid (Alpha Lipoic Acid) 600 mg HR Film Coated Tablets of Meda Pharma GmbH& CO .KG, Germany.
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San. Ve Tic. A.S.
- Trial name
- NCT04214665
- Testing
- Alpha Lipoic acid 600 mg HR film coated tablets
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ilko Ilac San. ve Tic. A.S.
Area Under Curve, Pharmacokinetics
The Safety and Pharmacokinetics of Primapur and Gonal-f
The purpose of the current phase I study was to establish bioequivalence, safety, and tolerance of single 300 IU subcutaneous dose of follitropin alfa biosimilar (Primapur) in comparison to that of reference follitropin alfa…
- Conditions
- Area Under Curve, Pharmacokinetics, Absorption
- Trial name
- NCT03857230
- Testing
- Follitropin alfa (Primapur), Follitropin alfa (Gonal-F)
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IVFarma LLC
Healthy
A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition
The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current marketed ULTRACET ER tablet, in healthy…
- Trial name
- NCT01778075
- Testing
- Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER), Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)
- Where
- South Korea
- Volunteers
- 56 people
- Sponsor
- Janssen Korea, Ltd., Korea
Diabetes, Healthy
Bioequivalence Between Two Explorative Insulin Degludec Formulations and Between Two Explorative IDegAsp Formulations in Healthy Subjects
This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin degludec/insulin aspart (IDegAsp …
- Trial name
- NCT01868581
- Testing
- insulin degludec, insulin degludec/insulin aspart
- Where
- Germany
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Mild Asthma
Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of Albuterol Base/Inh) of Macleods Pharmaceuticals Ltd
This is a pharmacodynamic bioequivalence bronchoprovocation study using single-dose, double-blind, double-dummy, randomized, study consisting of four study treatments (zero dose [Placebo], E.Q.
- Trial name
- NCT06618105
- Testing
- Albuterol Sulfate 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations
- Where
- India
- Volunteers
- 144 people
- Sponsor
- Macleods Pharmaceuticals Ltd
Healthy Participants
A Study to Evaluate the Bioequivalence of Single Oral Dose of Esomeprazole Capsule and Tablet Formulation in Healthy Participants
The purpose of this study is to determine the bioequivalence of esomeprazole 40 milligram (mg) tablets and capsules.
- Trial name
- NCT03083639
- Testing
- Esomeprazole Capsule, Esomeprazole Tablet
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
Food Study of Olanzapine Tablets 5 mg and Zyprexa® Tablets 5 mg
The objective of this study was to investigate the bioequivalence of Mylan olanzapine 5 mg tablets to Eli Lilly's Zyprexa® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administered under fed conditions.
- Trial name
- NCT00647777
- Testing
- Olanzapine Tablets 5 mg, Zyprexa® Tablets 5 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of pravastatin sodium 40 mg tablets with that of Pravachol® 40 mg tablets in healthy adult male subjects under fasting conditions.
- Trial name
- NCT00834379
- Testing
- pravastatin sodium, Pravachol®
- Where
- Canada
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence, Healthy Volunteers
A Study to Learn if There is a Difference in the Blood Levels of Acetylsalicylic Acid When Taken as Different Chewable Tablets on an Empty Stomach by Healthy Participants
In this study, researchers want to learn if 2 different forms of acetylsalicylic acid (ASA) chewable tablets will have the same effect in the body.
- Conditions
- Bioequivalence, Healthy Volunteers, Platelet Aggregation Inhibition
- Trial name
- NCT06655194
- Testing
- Acetylsalicylic Acid (Aspirin, BAYE004465, UI1610477), Acetylsalicylic Acid (BAYE004465, UI1615160)
- Where
- Mexico
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Bioequivalence Study of Cefprozil Tablets, USP 500 mg Undef Fed Conditions
The objective of this study is to assess the single - dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed conditions.
- Trial name
- NCT00778245
- Testing
- cefprozil 500mg tablets
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of…
- Trial name
- NCT02650973
- Testing
- CHS-1701, Pegfilgrastim
- Where
- 4 sites in United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Coherus Oncology, Inc.
Hypoglycemia
Bioequivalence of Fresenius Kabi USA, LLC Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories)
The primary objective of this study is to ascertain the pharmacokinetics (PK) and pharmacodynamics (PD) bioequivalence of a subcutaneous (SC) injection of 1 mg (1 IU) of Glucagon (Fresenius Kabi USA) in comparison to the…
- Trial name
- NCT02086227
- Testing
- Glucagon for Injection (Fresenius Kabi USA), Glucagon for Injection (Bedford Laboratories)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi USA, LLC
Acne Vulgaris
Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris
To evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% (Aleor Dermaceuticals Limited, India) and Differin® (Adapalene) Gel 0.3% (Galderma Laboratories, LP USA) in the treatment of acne vulgaris.
- Trial name
- NCT03650361
- Testing
- Adapalene Gel 0.3%, Differin 0.3% Topical Gel
- Where
- 10 sites in United States, Belize
- Volunteers
- 755 people
- Sponsor
- Aleor Dermaceuticals Limited
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