Clinical trials: Therapeutic Equivalency
Healthy
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
This study was designed to assess the bioequivalence between the test products (Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation) and the reference products (Proair HFA [Albuterol Sulfate] Inhalation Aerosol 90 mcg Per…
- Trial name
- NCT04803734
- Testing
- Albuterol Sulfate inhalation aerosol 108mcg per actuation, Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation
- Where
- Taiwan
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Intech Biopharm Ltd.
Healthy
Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and Akynzeo capsules by pharmacokinetic(PK) evaluation
- Trial name
- NCT04486157
- Testing
- IN-A012, Akynzeo 300Mg-0.5Mg Capsule
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Olanzapine Orally Disintegrating 5mg Tablets Under Fed Condition
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Olanzapine Orally Disintegrating 5 mg Tablets versus Zyprexa® Zydis® 5 mg Tablets (Reference formulation; Eli Lilly and…
- Trial name
- NCT01996501
- Testing
- Olanzapine Orally Disintegrating 5mg Tablets
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Fed Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available…
- Trial name
- NCT00853736
- Testing
- Roxicodone™ tablet 30 mg, Oxycodone hydrochloride tablet 30 mg
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy
Fasting Study of Metformin Hydrochloride ER Tablets 750 mg and Glucophage® XR Tablets 750 mg
The objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 750 mg (1 x 750 mg) dose administered under…
- Trial name
- NCT00648518
- Testing
- Metformin Hydrochloride ER Tablets 750 mg, Glucophage® XR Tablets 750 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Bioequivalence Study Comparing Irbesartan/Atorvastatin Combination Tablet With Coadministration of Irbesartan and Atorvastatin
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of Irbesartan and Atorvastatin in combination as HCP0912
- Trial name
- NCT01447797
- Testing
- HCP0912 / Irbesartan and Atorvastatin
- Where
- South Korea
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Healthy
Study to Determine the Bioequivalence of Two Products Containing Rosuvastatin (20 mg/Tablet)
The purpose of this study is to determine the bioequivalence of Rosuvastatin/ Verisfield 20 mg film-coated tablets and Crestor™/ AstraZeneca 20 mg film-coated tablets.
- Trial name
- NCT02767310
- Testing
- Rosuvastatin 20 mg film-coated tablets, Crestor 20 mg film-coated tablets
- Where
- India
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Verisfield UK Ltd. Greek Branch
Healthy Participants
Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition
This study is intended to establish bioequivalence of the bosutinib age-appropriate capsule formulation to the commercial tablet formulation in healthy participants under fed condition.
- Trial name
- NCT04549480
- Testing
- Bosutinib capsule, Bosutinib tablet
- Where
- 2 sites in Netherlands
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Pfizer
Infections, Respiratory Tract
A Bioequivalence Study of an Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil 2% Oral Solution
This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose crossover design study in adult male and female healthy participants.
- Trial name
- NCT02688361
- Testing
- Fluimucil® 2% solution, Acetylcysteine 2% solution
- Where
- Germany
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bioequivalence
A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT04564456
- Testing
- Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent, ADVAIR DISKUS® 500/50
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants
The purpose of this study is to evaluate the amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector, an injection under the skin, compared to…
- Trial name
- NCT06475729
- Testing
- Citrate-Free Mirikizumab
- Where
- 6 sites in United States
- Volunteers
- 498 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
A Relative Bioavailability Study of Bupropion XL 150 mg Tablets Under Fasting Conditions
To compare the rate and extent of absorption of Abrika Bupropion 150 mg XL Tablet to that of Wellbutrin XL® 150 mg Tablet after a single, one-tablet dose in fasted subjects.
- Trial name
- NCT00863941
- Testing
- Abrika Bupropion 150 mg XL Tablet, single dose, Wellbutrin XL® 150 mg Tablet, single dose
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Food Study of Escitalopram Oxalate Tablets 20 mg to Lexapro® Tablets 20 mg
The objective of this study was to investigate the bioequivalence of Mylan's escitalopram oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administered under fed conditions.
- Trial name
- NCT00648661
- Testing
- Escitalopram Oxalate Tablets 20 mg, Lexapro® Tablets 20 mg
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Type 2 Diabetes Mellitus (T2DM)
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, two way crossover, Oral Bioequivalence Study of test product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and…
- Trial name
- NCT07266766
- Testing
- Empagliflozin / Metformin HCl XR Tablets, Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence Study of Ibuprofen 200 mg Gel Capsules of Dr. Reddy's Laboratories Under Fasting Condition
The purpose of this study is to compare the rate and extent of absorption of ibuprofen 200 mg gelcaps (test) versus Advil liquigels (reference) administered as 1 x 200 mg gelcap under fasting conditions.
- Trial name
- NCT01149941
- Testing
- Ibuprofen
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Chronic Heart Failure
Bioequivalence Study to Compare Sacubitril and Valsartan Tablets (97mg/103mg) Versus Entresto® (Sacubitril and Valsartan) Tablets (97 mg/103 mg)
An open label, balanced, randomized, single dose, two treatment, two sequence, four period, full-replicate, oral bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of HUMANİS SAĞLIK ANONİM ŞİRKETİ Ç.O.S.B.…
- Trial name
- NCT06922253
- Testing
- Sacubitril and Valsartan-Test product, Sacubitril and Valsartan-Reference product
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Male and Female
The purpose of this trial is to investigate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and…
- Trial name
- NCT02266472
- Testing
- metformin, empagliflozin/metformin, empagliflozin
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Cerebrotendinous Xanthomatoses
Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) Versus Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules (250mg Chenodeoxycholic Acid)
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Chenodeoxycholic acid capsules (250mg chenodeoxycholic acid) [dose: 1 x 02 capsules] versus Chenodeoxycholic acid leadiant…
- Trial name
- NCT06180057
- Testing
- Chenodeoxycholic acid, Chenodeoxycholic acid leadiant
- Where
- Jordan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Health
Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet
This was an open-label, randomized, single-dose, two-period, two-sequence, cross-over study under fasting condition which included 24 healthy adult male and female subjects.
- Trial name
- NCT06817811
- Testing
- Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica), Eliquis® 5 mg film-coated tablet (Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia)
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Healthy Volunteer, Pharmacokinetics of YM150
A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B
This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.
- Trial name
- NCT01125657
- Testing
- YM150
- Where
- Japan
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
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