Clinical trials: Therapeutic Equivalency, Healthy
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
A Relative Bioavailability Study of Citalopram HBr 10 mg Tablets Under Fasting Conditions
The purpose of this study is compare the relative bioavailability of 10 mg Citalopram Hydrobromide tablets by Purepac Pharmaceutical Co with that of 10 mg CELEXATM tablets distributed and marketed by Forest Pharmaceuticals, Inc.
- Trial name
- NCT00865943
- Testing
- Citalopram HBr eq. 10 mg tablets, single dose, CELEXATM 10 mg tablets, single dose
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Infectious Diseases
Evaluate Bioequivalence of Burotam (1/1 g/Vial)
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of cefoperazone sodium and sulbactam sodium combination (1/1 g/vial) after intravenous infusion of 1 g cefoperazone sodium and 1 g…
- Trial name
- NCT05654090
- Testing
- cefoperazone sodium and sulbactam sodium
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Fed
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fed Conditions
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
- NCT01827878
- Testing
- Lisinopril and Hydrochlorothiazide Tablets (20+25) mg, Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Invasive Candidiasis
Evaluate Bioequivalence of Micafungin (50mg/Vial)
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of micafungin (50 mg/vial) after intravenous infusion of 50 mg micafungin in healthy volunteers under fasting conditions
- Trial name
- NCT05496725
- Testing
- Micafungin
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Healthy
90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company…
- Trial name
- NCT01247285
- Testing
- Fluoxetine Hydrochloride, PROZAC WEEKLY®
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions
The objective of this study was to compare the relative bioavailability of Lansoprazole DR Capsules 30 mg with Prevacid® Capsules 30 mg under fasting conditions in healthy adult human subjects.
- Trial name
- NCT01270308
- Testing
- Lansoprazole
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Epilepsy (treatment Refractory)
Bioequivalence Study of Two Brivaracetam Oral Solutions in Healthy Adults Under Fasting and High-Fat Meal Conditions
The goal of this clinical trial is to evaluate the bioequivalence of Brivaracetam oral solution under fasting and high-fat meal conditions in healthy adults.
- Trial name
- BE (NCT06762743)
- Testing
- Brivaracetam Oral Solution (Test Formulation), Brivaracetam Oral Solution (Reference Formulation)
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Healthy
Fed Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium-delayed-release tablets 500 mg tablets to Abbott's Depakote® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose…
- Trial name
- NCT01183676
- Testing
- DEPAKOTE® Tablets, 500 MG, DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Amoxicillin Dispersible 600 mg Tablets Under Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of amoxicillin tablets for oral suspension 600 mg by Ranbaxy Laboratories Limited with that of Amoxil ® for oral suspension 400 mg/ 5 mL by…
- Trial name
- NCT00778050
- Testing
- Amoxicillin 600mg
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Subjects
Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin
Monotherapies for lowering LDL-C often do not achieve target lipid levels because they act on a single pathway, which may be insufficient in patients with high cardiovascular risk or complex lipid profiles.
- Trial name
- NCT07268625
- Testing
- Bempedoic acid, Ezetimibe, Atorvastatin
- Where
- Portugal
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Healthy
Phase1, Single Dose, Crossover Study to Determine Bioequivalence
The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D and formulation E(1).
- Trial name
- NCT00786240
- Testing
- Fesoterodine
- Where
- Singapore
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence Pilot Study of Dirithromycin of (Abdi İbrahim İlaç San.Ve.Tic.A.Ş,Turkey) in Healthy Subjects Under Fasting Condition
To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Erythromycylamine and calculation of the bioequivalence parameters from those…
- Trial name
- NCT02185833
- Testing
- DIRITHROMYCIN 500 MG ENTERIC COATED TABLET, DYNABAC 250 MG ENTERIC COATED TABLET
- Where
- Jordan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pharmaceutical Research Unit, Jordan
Healthy Volunteers
A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions (Study 013-10)
The primary objective of this study is to compare the bioavailabilities of a single fixed dose combination of eperisone 50 mg plus diclofenac 50 mg capsules with the bioavailabilities of eperisone 50 mg tablets and diclofenac 50…
- Trial name
- NCT01306318
- Testing
- eperisone hydrochloride plus diclofenac sodium capsule, eperisone hydrochloride tablet and diclofenac sodium tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Healthy
ABX-002 Bioequivalence and Effect of Food Study in Healthy Adult Participants
The goal of this study is to assess the bioequivalence (BE) between the liquid formulation and the new solid formulation of ABX-002 under fasting conditions and to evaluate the effect of food on the pharmacokinetics (PK) of the…
- Trial name
- NCT07652697
- Testing
- ABX-002
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Autobahn Therapeutics, Inc.
Healthy
Bioequivalence Study Comparing Two Formulations of Escitalopram
This is a bioequivalence study, which is a regulatory requirement to ensure comparable in vivo performance, i.e. similarities in terms of safety and efficacy, after administration of two different dosage forms of escitalopram.
- Trial name
- NCT01395433
- Testing
- Escitalopram
- Where
- Netherlands
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
Relative Bioavailability of 2 Oral Formulations of Nintedanib
To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib compared to 2 soft gelatine capsules containing 100 mg nintedanib
- Trial name
- NCT02572752
- Testing
- Nintedanib
- Where
- Germany
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.
- Trial name
- NCT00877955
- Testing
- alprazolam sublingual tablet commercial, alprazolam sublingual tablet test
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy Volunteer
Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
- Trial name
- NCT02100917
- Testing
- DMB-3111, trastuzumab
- Where
- Japan
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Meiji Seika Pharma Co., Ltd.
Healthy
Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed Condition
The purpose of this bioequivalence study is to compare a test Glimepiride 1 mg tablets of Dr.Reddy's Laboratories Limited versus reference Amaryl 1 mg tablets of Aventis Pharmaceuticals Inc in healthy subjects, under fed…
- Trial name
- NCT01053689
- Testing
- Glimepiride tablets 1 mg
- Where
- Canada
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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