Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
Fasting Study of Oxybutynin Chloride Extended-Release Tablets 15 mg and Ditropan XL® Tablets 15 mg
The objective of this study was to investigate the bioequivalence of Oxybutynin Chloride Extended-Release Tablets, 15 mg (Mylan Pharmaceuticals Inc.) to Ditropan XL® Extended- Release Tablets, 15 mg (ALZA Corporation; Distributed…
- Trial name
- NCT00649272
- Testing
- Oxybutynin Chloride Extended-Release Tablets, 15 mg, Ditropan XL® Extended-release tablets, 15 mg
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Diabetes
Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects
The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard to its total and to its maximum serum insulin concentrations.
- Trial name
- NCT00772265
- Testing
- Wosulin N, Novolin N
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Healthy
Bioequivalence Study of Two Strengths of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects
Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in the strengths of 1000 mg (part I) and 500 mg (part II)
- Trial name
- NCT02183571
- Testing
- Merck Glucophage® high dose, BMS Glucophage® high dose, Merck Glucophage® low dose
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Fasting Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mg
The objective of this study was to investigate the bioequivalence of Mylan's meloxicam 15 mg tablets and Boehringer Ingelheim's Mobic® 15 mg tablets following a single, oral 15 mg (1 x 15 mg) dose administration under fasting…
- Trial name
- NCT00649077
- Testing
- Meloxicam Tablets 15 mg, Mobic® Tablets 15 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalency
Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fasting Conditions
Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fasting conditions.
- Trial name
- NCT00804401
- Testing
- Naproxen Tablets, 500 mg
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Perrigo Company
Healthy
Amoxicillin-Clavulanic Acid 400 Mg-57 mg Chewable Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin® (reference) administered as 1 x 400 mg-57 mg chewable tablet under…
- Trial name
- NCT00836901
- Testing
- amoxicillin-clavulanic acid, Augmentin®
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence Study
A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
Primary objective is to is to evaluate the bioequivalence of two formulations
- Trial name
- NCT06273254
- Testing
- Sacubitril and Valsartan Tablets 49mg/51mg, Entresto® (Sacubitril and Valsartan Tablets 49mg/51mg)
- Where
- Thailand
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Viatris Inc.
Healthy
Fasting Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg
The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered…
- Trial name
- NCT00649662
- Testing
- Ciprofloxacin Extended-Release Tablets 1000 mg, Cipro® XR Tablets 1000 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Volunteers
Zoliflodacin Bioequivalence and Drug-Drug Interaction Study
this study will be a Phase 1, single-dose, two parallel cohorts, open-label, randomized study in healthy subjects with Cohort 1 as bioequivalence (BE) and food effect study and Cohort 2 as a drug-drug interaction (DDI) study.
- Trial name
- NCT05635305
- Testing
- Zoliflodacin Patheon
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Global Antibiotics Research and Development Partnership
Healthy Volunteer
The Bioequivalence Study of Alfuzosin 10 mg Prolong-released Tablets Under Fed Conditions
Objective: Primary objective of the present study was to assess the relative bioavailability of Alfuzosin 10 mg Prolong-released Tablets under Fed conditions, in Healthy Thai Male Volunteers after an oral administration with 7…
- Trial name
- NCT06228339
- Testing
- Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, Xatral® XL 10 mg
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy
A Study of Mirikizumab in Healthy Participants
The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or…
- Trial name
- NCT04607733
- Testing
- Mirikizumab Prefilled Syringe, Mirikizumab Autoinjector
- Where
- 4 sites in United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Bioequivalence Study of Felodipine ER Tablets 10 mg Under Fasting Conditions
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Felodipine extended release tablets USP 10 mg (containing felodipine…
- Trial name
- NCT02327247
- Testing
- Felodipine, PLENDIL®
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy 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
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) in Healthy Adult Males
The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form taken without water and brotizolam conventional tablets (Lendormin® tablets) taken with water, was evaluated in healthy adult male subjects…
- Trial name
- NCT02218658
- Testing
- WE941 OD tablets, Brotizolam
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Food 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 an oral, single 20 mg (4 x 5 mg) dose under…
- Trial name
- NCT00648843
- Testing
- Oxybutynin Chloride Extended-release Tablets 5 mg, Ditropan XL® Tablets 5 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Fasting State
Bioequivalence Study of Carvedilol Tablets USP 12.5 mg Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01577914
- Testing
- Carvedilol Tablets USP 12.5 mg, Carvedilol
- Where
- India
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Bioavailability Study of Valacycovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fed Condition
The purpose of this study is to 1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl tablets of Dr.
- Trial name
- NCT01136538
- Testing
- Valacyclovir Hydrochloride
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers
The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers.
- Trial name
- NCT06254235
- Testing
- The test octreotide microsphere, The reference octreotide microsphere
- Where
- China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr.
- Trial name
- NCT01064115
- Testing
- Cetirizine Hydrochloride
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Comparative Study of New Formulation and Approved Formulation for Levothyroxine in Healthy Volunteers
The study investigated the bioequivalence between the new and the approved formulation for levothyroxine.
- Trial name
- NCT03979274
- Testing
- Reference Eutirox®, Test Eutirox®
- Where
- Mexico
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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