Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
The purpose of this study is to evaluate the relative bioavailability of two formulations of nabumetone tablets to establish their average bioequivalence
- Trial name
- NCT00864604
- Testing
- Nabumetone 750 mg tablets, single dose
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy Volunteers
A Bioequivalence Study Between Capozide Versus ACE-Hemmer-ratiopharm in Healthy Adult Participants Under Fasting Conditions
This is a bioequivalence study to compare Capozide (test product [T]) to ACE-Hemmer-ratiopharm (reference product[R]) produced by Ratiopharm GmbH Germany in healthy adult participants under fasting conditions.
- Trial name
- NCT04964050
- Testing
- Capozide, ACE-Hemmer-Ratiopharm
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State
The purpose of this study is to demonstrate bioequivalence of coadministered drugs on healthy subjects.
- Trial name
- NCT02223065
- Testing
- Saxagliptin, Dapagliflozin
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Opioid Induced Constipation
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.
- Trial name
- NCT01623609
- Testing
- Naloxegol
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pain
A Study of Whether 2 New Oral Formulations of a Strong Pain Killer Release the Same Amount of Drug Into the Body as the Marketed Medication
To determine whether two new oral formulations of a strong pain killer release the drug into the body in a similar pattern as the already marketed reference capsule formulation with or without food.
- Trial name
- NCT02089581
- Testing
- Active comparator MR2XXX, MRXXX, MR1XXX
- Where
- 2 sites in United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mundipharma Research Limited
Healthy
Food Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mg
The objective of this study was to investigate the bioequivalence of Mylan's quinapril HCl and hydrochlorothiazide 20 mg/25 mg tablets to Parke-Davis' Accuretic™ 20mg/ 25 mg tablets following a single, oral 20/25 mg (1 x 20/25…
- Trial name
- NCT00648011
- Testing
- Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg, Accuretic™ Tablets 20 mg/25 mg
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Insomnia
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.
- Trial name
- NCT01055834
- Testing
- Eszopiclone 3 mg, Eszopiclone 1 mg
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Healthy
Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.
The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test…
- Trial name
- NCT00840216
- Testing
- Clarithromycin ER 500 mg tablets, BIAXIN® XL 500 mg tablets
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Contraception, Contraception, Postcoital
Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods.
- Trial name
- LEVEQ-2 (NCT01096498)
- Testing
- Levonorgestrel Emergency Pill (BAY86-5028/Opxion), Levonorgestrel (Postday)
- Where
- Mexico
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers
Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption
The purpose of this study is to compare the bioavailability of two oral formulations of Triazolam in healthy volunteers, in order to determine that they are bioequivalent.
- Trial name
- NCT01017926
- Testing
- Triazolam
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Benign Prostatic Hyperplasia
Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers After Meal
This study is an open-label, randomized, fed, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc.
- Trial name
- NCT03887871
- Testing
- Harnal-D Tab., Chong Kun Dang Tamsulosin HCl Tab.
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy Subjects
Bioequivalence Study of Different Aprocitentan Tablet Formulations
The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations.
- Trial name
- NCT05196399
- Testing
- Aprocitentan (Formulation A), Aprocitentan (Formulation B)
- Where
- Czechia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Obstructive Sleep Apnea
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
The goal of this randomised four-period cross-over Phase I study is to assess bioavailability, bioequivalence and tolerability of IHL-42X compared to the reference drugs in healthy volunteers.
- Trial name
- NCT05857384
- Testing
- IHL42X, Acetazolamide 250 MG, Dronabinol 2.5 MG
- Where
- 4 sites in Australia
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Incannex Healthcare Ltd
Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin
Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin Produc
Study in healthy subjects to measure amount of drug in blood after dosing with different saxagliptin / metformin products.
- Trial name
- NCT01441869
- Testing
- Onglyza (saxagliptin), Diabex, 5-mg saxagliptin/1000 mg metformin
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioequivalence Study in Healthy Subjects
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 500 mg Tablets Under Fed Conditions.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL25-PC016 (NCT07633054)
- Testing
- Synjardy 5/850 mg tablet, Reference, Empagliflozin/metformin 12.5/500 mg test
- Where
- Mexico
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- ADIUM
Healthy
Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5mL Under Fed Condition
The purpose of this study is to compare the single-dose oral bioavailability of oxcarbazepine 300 mg/5mL oral suspension of OHM Laboratories, USA (a subsidiary of Ranbaxy Pharmaceuticals Inc.) with Trileptal® 300 mg/5mL oral…
- Trial name
- NCT00951847
- Testing
- oxcarbazepine 300 mg/5 mL oral suspension
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Bacterial Infection
Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
- Trial name
- NCT00939562
- Testing
- doxycycline monohydrate tablet, doxycycline carragenate tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Food Study of Modafinil Tablets 200 mg to Provigil® Tablets 200 mg
The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg tablets to Cephalon Provigil® 200 mg tablets following a single, oral 200 mg (1 x 200 mg) dose administration under fed conditions.
- Trial name
- NCT00650286
- Testing
- Modafinil Tablets 200 mg, Provigil® Tablets 200 mg
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Influenza, Respiratory Viral Infection
Pharmacokinetics and Bioequivalence of XC8 10 mg and 40 mg Tablets in Fasted Volunteers
Comparative study of the pharmacokinetics of XC8, film-coated tablets, 10 mg and XC8, film-coated tablets, 40 mg, when administered once in equal doses (40 mg) on an empty stomach in healthy volunteers.
- Trial name
- NCT05558462
- Testing
- XC8
- Where
- Russia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Type 2 Diabetes Mellitus
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin IR tablet co-administered to…
- Trial name
- NCT00899470
- Testing
- Co-administration of Saxagliptin and Metformin IR, Fasted, Saxagliptin/Metformin, Fasting, Co-administration of Saxagliptin and Metformin IR, Fed
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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