Clinical trials: Bioequivalence Study in Healthy Subjects
Fasting
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fasting Condition
The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fasting conditions and to monitor adverse events and ensure safety of subjects.
- Trial name
- NCT01503437
- Testing
- Olanzapine OD Tablets 5 mg
- Where
- India
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Anxiety Disorders
Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) and paroxetine IR tablets have been approved for the treatment of three anxiety indications in China.
- Trial name
- NCT03329573
- Testing
- Paroxetine IR tablets A, Paroxetine IR tablets B
- Where
- China
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg…
- Trial name
- NCT02060201
- Testing
- Saxagliptin, Dapagliflozin, Saxagliptin/Dapagliflozin FDC
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare the rate and extent of absorption of ranitidine 300 mg tablets versus Zantac 300 mg tablets administered as 1 x 300 mg tablet under fasting conditions.
- Trial name
- NCT01131702
- Testing
- Ranitidine
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fed Conditions
The purpose of this study is To compare the single oral dose bioavailability of test product, Trandolapril 4 mg Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult, human subjects, under fed…
- Trial name
- NCT01164800
- Testing
- Trandolapril, Mavik
- Where
- India
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Fed Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin® Capsules 1 mg
The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1 mg capsules to Shire US's Agrylin® 1 mg capsules following a single, oral 1 mg (1 x 1 mg) dose administration under fed conditions.
- Trial name
- NCT00648765
- Testing
- Anagrelide Hydrochloride Capsules 1 mg, Agrylin® Capsules 1 mg
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers
Bioequivalence Study With Pharmacokinetic Endpoints, Comparing a Single Dose of Iron Sucrose Azad Injection of Azad Pharma Corporation (AG), With a Single Dose of Venofer® Injection of Vifor Corporation (AG) in Healthy Adult Volunteers
A Clinical Trial to Demonstrate the Comparability of the Two Iron Sucrose Injection Solutions Iron Sucrose Azad of Azad Pharma AG and Venofer® of Vifor Pharma AG.
- Trial name
- NCT02391181
- Testing
- Iron Sucrose Azad, Venofer®
- Where
- Austria
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Azad Pharma AG
Bioequivalence Study in Healthy Subjects, PK/PD
Bioavailability and Bioequivalence Study of ER Torsemide and Spironolactone FDC Tablet in Healthy Subjects
This study examines the bioavailability and bioequivalence of single dose of a Fixed Dose Combination (FDC) tablet (12 mg Extended-Release Torsemide and 15mg Spironolactone).
- Trial name
- NCT07015671
- Testing
- 10 mg Torsemide tablet, 25 mg Aldactone (Spironolactone) tablet, FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sarfez Pharmaceuticals, Inc.
Bioequivalence
Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg
The primary aim of this study is to demonstrate bioequivalence in the rate and extent of absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of 1600 μg, twice a day (b.i.d.) and 1600 μg…
- Trial name
- NCT02206295
- Testing
- selexipag
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Actelion
Healthy
Food Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mg
The objective for this study was to investigate the bioequivalence of Mylan's verapamil HCl extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules following a single, oral 300 mg (1 x 300 mg)…
- Trial name
- NCT00648401
- Testing
- Verapamil Hydrochloride Extended-Release Capsules, 300 mg, Verelan® PM Extended-Release Capsules, 300 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Subjects
A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects
This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm).
- Trial name
- NCT02279485
- Testing
- Perampanel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Therapeutic Equivalency
Fed, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Subjects
This study was designed to compare the rate and extent of absorption of pravastatin sodium from the following formulations under fed conditions: 1. Pravastatin Sodium 80 mg Tablets (Genpharm Inc. Canada) 2.
- Trial name
- NCT00648544
- Testing
- Pravastatin
- Where
- Canada
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Fasting BE Study of Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR Tablets 500 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 500 mg (1 x 500 mg) dose administered under…
- Trial name
- NCT00650234
- Testing
- Metformin Hydrochloride ER Tablets 500 mg, Glucophage® XR Tablets 500 mg
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence
Bioequivalence Study of Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (Pharmtechnology LLC, Belarus), and Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject will be randomly assigned to the reference or the test formulation in each…
- Trial name
- NCT03616301
- Testing
- Clavamox, Augmentin®
- Where
- Russia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Diabetes Mellitus, Type 2
Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed and approved for the treatment of type 2 diabetes mellitus.
- Trial name
- NCT02660736
- Testing
- Albiglutide Liquid Auto-injector, Albiglutide Lyophilized DCC Pen Injector
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pharmacokinetics
Fasting Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers
The primary objective was to compare the rate and extent of absorption of Metformin XR after administration of a Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR…
- Trial name
- NCT05123781
- Testing
- Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine), Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK)
- Where
- Czechia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Psoriasis and Psoriatic Arthritis
Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects
An open label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover, bioequivalence study in normal, healthy, adult, human subjects under fasting condition
- Trial name
- NCT06084663
- Testing
- Apremilast 30 mg Tablets, Otezla 30 mg film-coated tablets
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Rosacea
Bioequivalence Study of Ivermectin 1% Cream and Soolantra (Ivermectin) 10 mg/g Cream
Single dose bioequivalence study of Ivermectin 1% cream and Soolantra (Ivermectin) 10 mg/g cream in healthy adult human subjects.
- Trial name
- NCT06557603
- Testing
- Ivermectin cream, Soolantra ® (Ivermectin) cream
- Where
- India
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Fasting
Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under 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
- NCT01283841
- Testing
- Mycophenolate Mofetil
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Type 2 Diabetes
Bioequivalence Study of Test Product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg Film Coated Tablets and Reference Product (R) of Segluromet 7.5 mg/ 1000 mg Film Coated Tablets in Healthy, Adult, Human Subjects Under Fed Condition.
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, Two way crossover, Oral Bioequivalence Study of test product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg film coated tablets of Humanis…
- Trial name
- NCT07266779
- Testing
- Ertugliflozin/Metformin film coated tablets, Segluromet film coated tablets
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
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