Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fasted Conditions
Objective: To compare the rate and extent of absorption of Zolpidem Tablets 10mg: Test Product: Zolpidem Tablets 10mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: Ambien® Tablets 10 mg (Reference…
- Trial name
- NCT00939536
- Testing
- Zolpidem Tartrate Tablets 10 mg
- Where
- India
- Volunteers
- 24 people
- Sponsor
- Torrent Pharmaceuticals Limited
Bioequivalence Study
Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions
The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence Study. During each session, the subjects will be administered a single dose of 250mg Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan…
- Trial name
- NCT03050164
- Testing
- Gefitinib Tablet 250mg of Hunan Kelun, Iressa® Tablet 250mg of AZN
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.
Bioequivalence
Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions
Single oral administrations of study drug (Lamnet and Lamictal) in two periods separated by a washout period of 14 days. The washout period will be calculated from day of dosing (Day 2) to at least 14 days post dose in each…
- Trial name
- BE (NCT04938856)
- Testing
- Lamotrigine tablet
- Where
- Pakistan
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Karachi
Bioequivalence
Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273
The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions.
- Trial name
- NCT06164431
- Testing
- ZSP1273 tablet, zsp1273 granules
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Healthy
Equivalence of Resorption of Empagliflozin/Metformin Administered as Combination Tablet Compared With Empagliflozin/Metformin as Single Tablets Administered Together
Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin…
- Trial name
- NCT01811953
- Testing
- Empagliflozin, Metformin, Empagliflozin/Metformin
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bioequivalence Study
Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream
To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults
- Trial name
- NCT04358770
- Testing
- Clocortolone Pivalate
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Healthy Subjects
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to…
- Trial name
- B538-07 (NCT02237729)
- Testing
- PF-06410293, Adalimumab-US, Adalimumab-EU
- Where
- 8 sites in United States
- Volunteers
- 362 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bioequivalence
Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson&Jonson", Russia)
Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson\&Jonson", Russia)
- Trial name
- NCT04268472
- Testing
- GP30101, Prezista®
- Where
- Russia
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Geropharm
Parkinson Disease
Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone
The purpose of this study is to evaluate the bioavailability and the bioequivalence between two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage strengths (25 mg and 50 mg) after a single…
- Trial name
- NCT03116295
- Testing
- Opicapone (OPC)
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy
Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fed Conditions
To compare the bioavailability and characterize the pharmacokinetic profile of the Sponsor's formulation (Clopidogrel Bisulfate 300 mg Tablets) with respect to the reference formulation (Plavix® 300 mg tablets) in healthy, adult…
- Trial name
- NCT01621763
- Testing
- Clopidogrel
- Where
- India
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Tobacco Use Disorder
A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers
The purpose of this study is to assess the bioequivalence of the 21mg nicotine transdermal patch from GSK Dungarvan (Test) compared to the 21mg nicotine transdermal patch currently manufactured by Alza (Reference).
- Trial name
- NCT05024747
- Testing
- NicoDerm CQ patch (GSK Dungarvan), NicoDerm CQ (Alza)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- HALEON
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.
Healthy
A Study of Baricitinib in Healthy Participants
The purposes of this study are to determine: If there are any differences in the amount of baricitinib in the blood/body when taken in two different forms.
- Trial name
- NCT03212638
- Testing
- Baricitinib suspension, Baricitinib tablet
- Where
- Singapore
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions
This is an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT03706300
- Testing
- Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg
- Where
- India
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Therapeutic Equivalency
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
A single center, single dose, open-label, randomized, two period crossover study to assess the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma…
- Trial name
- AZA (NCT03930264)
- Testing
- Azathioprine 50Mg Tab, Azathioprine 10mg/mL oral suspension
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nova Laboratories Limited
Benign Prostatic Hyperplasia (BPH)
PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination
To compare the relative bioavailability and pharmacokinetic characteristics of a newly single pill combination of finasteride and tamsulosin with a conventional combination of finasteride and tamsulosin in healthy subjects with a…
- Trial name
- NCT01829893
- Testing
- In combination of 0.2mg finasteride and 5mg tamsulosin, GL2701 capsule
- Where
- South Korea
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Korea University Anam Hospital
Asthma, Bioequivalence
A Bioequivalence Study Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions
Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder
- Trial name
- NCT05021887
- Testing
- Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals, FLOVENT DISKUS
- Where
- Greece
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
Food Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan quinapril hydrochloride 40 mg tablets compared to Parke-Davis Accupril® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose under fed conditions.
- Trial name
- NCT00649649
- Testing
- Quinapril Hydrochloride Tablets 40 mg, Accupril® Tablets 40 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
The purpose of this study is assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of…
- Trial name
- NCT00415922
- Testing
- ELC200 (carbidopa+levodopa+entacapone)
- Where
- Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Novartis
Fasting
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fasting Condition
The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fasting conditions and to monitor adverse events and ensure safety of subjects.
- Trial name
- NCT01503437
- Testing
- Olanzapine OD Tablets 5 mg
- Where
- India
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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