Clinical trials: Bioequivalence
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.
Bioequivalence
Effects of Altered Formulation on the Bioequivalence of Tacrolimus in Healthy Female and Male Volunteeers
Amorphous solid dispersion (ASD) formulations are increasingly used by the pharmaceutical industry to develop poorly water-soluble drugs into effective oral dosage forms.
- Trial name
- ASDBioequiv (NCT02341274)
- Testing
- Tacrolimus
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Indiana University
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
Hypogonadism
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection…
- Trial name
- NCT03792477
- Testing
- Test formulation, Reference formulation
- Where
- 2 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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 Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions
The objective of this study was to evaluate the relative bioavailability of the test formulation of finasteride 5 mg tablets (Dr.
- Trial name
- NCT01264302
- Testing
- Finasteride
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteer
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.
- Trial name
- NCT02053753
- Testing
- Denosumab CP4, Denosumab CP2
- Where
- 2 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy
Bioequivalence Study of UHAC62XX Tablets Compared With Capsules in Healthy Volunteers
Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.
- Trial name
- NCT02187575
- Testing
- UHAC 62 XX tablet, UHAC 62 XX capsule
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5 mL Under Fasting Conditions
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single- dose, crossover bioavailability study comparing oxcarbazepine 300 mg/5mL oral suspension of OHM Laboratories (a…
- Trial name
- NCT00951600
- Testing
- oxcarbazepine 300 mg/5mL oral suspension
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Subjects
PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers
A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults
- Trial name
- NCT07256600
- Testing
- DWJ1445, DWC202506
- Where
- South Korea
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Atopic Dermatitis
Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis
A phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter study to evaluate the safety and bioequivalence of Par Pharmaceutical Inc.'s Pimecrolimus Cream, 1% and Reference Listed Elidel® (Pimecrolimus…
- Trial name
- NCT03297502
- Testing
- pimecrolimus cream 1%, Elidel (pimecrolimus) cream 1%
- Volunteers
- 582 people
- Sponsor
- Par Pharmaceutical, Inc.
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
HIV/AIDS
Triomune Bioequivalence With Innovators
The null hypothesis is that there is a difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans and the…
- Trial name
- NCT01025830
- Testing
- Triomune, Zerit/Epivir/Viramune
- Where
- Uganda
- Volunteers
- 20 people
- Sponsor
- Makerere University
T2DM (Type 2 Diabetes Mellitus)
Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets
This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation…
- Trial name
- NCT07519265
- Testing
- Chiglitazar/Metformin extended-release fixed-dose combination tablet, dose 1, Chiglitazar tablet, dose 1, Metformin extended-release tablet, dose 1
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Chipscreen Biosciences, Ltd.
Healthy
Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System
The objective of this study was primarily to investigate the bioequivalence and secondly to assess the wearability (adhesion) and acute irritation of Mylan fentanyl transdermal system with and without an overlay system following…
- Trial name
- NCT00647842
- Testing
- Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay, Fentanyl Transdermal System 25 mcg/h
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Male and Female Subjects
A Comparative Bioavailability Study of Reformulated Ibuprofen 2% and 4% Oral Suspensions (Berlin Chemie AG) and Versus Ibuprofen (Nurofen®) 200 mg/5 ml Oral Suspension
Purpose of the study is to compare three different formulations of Ibuprofen oral suspension (liquid taken by mouth) to see if there are any differences in how much of the active substance and how quickly it was taken up by by…
- Trial name
- NCT07036861
- Testing
- Ibuprofen 2%, Ibuprofen 4%
- Where
- 2 sites in Lithuania
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group