Clinical trials: Bioequivalence
Healthy
Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions
The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd.
- Trial name
- NCT01511757
- Testing
- Fluconazole
- Where
- Canada
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Partial Onset Epilepsy
A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.
- Trial name
- NCT01240187
- Testing
- perampanel
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy
A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and…
- Trial name
- NCT01463228
- Testing
- A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets), B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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 Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.
- Trial name
- NCT01627834
- Testing
- Ropinirole
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 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 hydromorphone 8 mg to an equivalent oral dose of a commercially…
- Trial name
- NCT00853554
- Testing
- Hydromorphone Hydrochloride tablet 8 mg, Dilaudid® tablet 8 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy, Obese
A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese…
- Conditions
- Healthy, Obese, Overweight, Obesity
- Trial name
- NCT06440980
- Testing
- Orforglipron
- Where
- 7 sites in United States
- Volunteers
- 533 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Bioavailability Study of Sirolimus Tablets 2 mg Under Fed Condition
This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy, adult,human subjects under Fed conditions.
- Trial name
- NCT02296762
- Testing
- Sirolimus
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Male Subjects
Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers
This trial is conducted in China. The purpose of this study is to evaluate the pharmacokinetic similarity of Tafolecimab with different manufacturing process in healthy male subjects.
- Trial name
- NCT05792917
- Testing
- tafolecimab (a modified manufacturing process), tafolecimab (a original manufacturing process)
- Where
- China
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Prostatic Hyperplasia
A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.
Dutasteride and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when given together, there is more improvement in symptoms than either drug alone.
- Trial name
- NCT00609596
- Testing
- GI198745
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Primary Hypogonadism, Hypogonadotropic Hypogonadism
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
- Trial name
- NCT02110368
- Testing
- Testosterone Topical Gel, 1.62% Metered Pump, AndroGel (testosterone gel) 1.62% Metered-Dose Pump
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Healthy
Ursodiol Tablets 500 mg Under Fasting Conditions
The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference) after a single-dose in healthy subjects under fasting conditions.
- Trial name
- NCT00909610
- Testing
- Ursodiol, Urso Forte™
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Chronic Idiopathic Constipation
Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).
- Trial name
- NCT03097861
- Testing
- Lubiprostone
- Where
- 67 sites in United States
- Volunteers
- 552 people
- Sponsor
- Sucampo Pharma Americas, LLC
Healthy Volunteers
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fed Condition
The objective of the study is to compare the bioavailability and characterise the pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil…
- Trial name
- NCT01080417
- Testing
- Mycophenolate Mofetil Capsule 250 mg
- Where
- India
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Major Depressive Disorder
A Study of LY03005 vs Pristiq
The objective of this study is to evaluate relative bioavailability between 80 mg LY03005 oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over 2-period design under fasting condition in…
- Trial name
- NCT03733574
- Testing
- LY03005, Pristiq
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Metastatic Adenocarcinoma of the Pancreas
A Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and BR2021-1
The purpose of this clinical study is to compare and evaluate the pharmacokinetic characteristics and the safety between administration of BR2021 and BR2021-1 in patients with metastatic adenocarcinoma of the pancreas
- Trial name
- NCT06867497
- Testing
- BR2021, BR2021-1
- Where
- 2 sites in South Korea
- Volunteers
- 20 people
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Bilateral Cataract
A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
Each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye.
- Trial name
- TBO (NCT02734459)
- Testing
- cataract surgery
- Volunteers
- 756 people
- Sponsor
- Semler Research Center Pvt. Ltd.
Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate
A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients
The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM) Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in patients with cancer.
- Trial name
- NCT02162888
- Testing
- Test Product (Bendamustine)
- Where
- 10 sites in United States
- Volunteers
- 81 people
- Sponsor
- Eagle Pharmaceuticals, Inc.
Glaucoma
Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes
This is a randomized, double blind, two-arm, parallel group, active controlled bioequivalence study, at multiple clinical trial sites designed to demonstrate bioequivalence of Brinzolamide 1% ophthalmic suspension (manufactured…
- Trial name
- NCT02512042
- Testing
- Test-Brinzolamide 1% Ophthalmic suspension, Reference-Brinzolamide 1% Ophthalmic suspension
- Where
- 10 sites in United States
- Volunteers
- 973 people
- Sponsor
- Actavis Inc.
Healthy
Finasteride 5 mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of finasteride 5 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of PROSCAR® 5 mg tablets (Merck) in healthy, adult…
- Trial name
- NCT00835666
- Testing
- Finasteride 5 mg tablets, PROSCAR®
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA