Clinical trials: Therapeutic Equivalency, Healthy
Healthy
Bioequivalence of Two Formulations of Meropenem Intravenous Injection
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of meropenem (meropenem intravenous injection 0.5 g) after intravenous infusion in healthy volunteers.
- Trial name
- NCT02344563
- Testing
- Meropem, Mepem
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Healthy Volunteer Male Subjects
A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets, in Healthy Adult Male Subjects, Under Fasting Conditions
The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg…
- Trial name
- NCT07156916
- Testing
- Tamsulosin (0.4 mg/j)
- Where
- Armenia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Antifungal Agents
Bioequivalence (BE) Study of Test Griseofulvin 500 Milligram (mg) Tablets Versus Reference and Dose Proportionality Study of Test Griseofulvin 250 mg and 500 mg Tablets Under Fed Conditions
Griseofulvin is an antifungal agent used in treatment of Dermatophytosis caused by Microsporum spp. (species), Trichophyton spp., Epidermophyton spp., where topical therapy is considered inappropriate or has failed.
- Trial name
- NCT04318535
- Testing
- Griseofulvin 500 mg, Griseofulvin 250 mg, Reference Griseofulvin 500 mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product
This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies and the capsule that is being…
- Trial name
- NCT01906125
- Testing
- palbociclib capsule: phase 1 and 2 studies, Palbociclib capsule: phase 3 studies, Palbociclib capsule: ICH
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc.
- Trial name
- NCT01074463
- Testing
- Pramipexole Dihydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Hepatocellular Carcinoma
A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
A clinical trial to compare the pharmacokinetics and bioequivalence of BR2008 with BR2008-1 in healthy volunteers
- Trial name
- NCT05068193
- Testing
- BR2008-1 (R), BR2008 (T)
- Where
- South Korea
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Healthy Volunteers
A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination Tablet With Coadministration of Cilnidipine and Valsartan
A randomized, open-label, single dosing, two-way crossover clinical trial to compare the safety/tolerability and pharmacokinetics of the combination of Cilnidipine 10mg and Valsartan 160mg in comparison to each component…
- Trial name
- NCT02088008
- Testing
- cinidipine, valsartan
- Where
- South Korea
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Multiple Sclerosis
Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy Volunteers
Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the active ingredient of Avonex®, that does not include fetal bovine serum (FBS).
- Trial name
- NCT01500408
- Testing
- Interferon beta-1a (current approved manufacturing process invloving FBS), Interferon beta-1a (new process, manufactured without FBS)
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Biogen
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
Healthy Subjects
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fed Condition
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233149
- Testing
- Esomeprazole magnesium dihydrate-Test product, Esomeprazole magnesium dihydrate-Reference product
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition
The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions
- Trial name
- NCT01888289
- Testing
- Isotretinoin
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Pergoveris FD and Liquid China BE Study
The main purpose of this study is to assess the bioequivalence (BE) of the fixed combination of follitropin alfa and lutropin alfa in Pergoveris freeze-dried (FD) (Test 1) or in Pergoveris Liquid (Test 2) versus the…
- Trial name
- NCT04899193
- Testing
- Pergoveris FD, Pergoveris Liquid, Gonal-f
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy
Bioequivalence Study Between "DA-5215 Tab" and "DA-5215-R Tab"
An Open-Label, Randomized, Fasting Condition, Single-dose, Cross-over Study to Evaluate the Bioequivalence between "DA-5215 Tab" and "DA-5215-R Tab" in Healthy Volunteers
- Trial name
- NCT05376085
- Testing
- DA-5215 Tab, DA-5215-R Tab
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Bioequivalence Study in Healthy Subjects
Rivastigmine Transdermal Patches Bioequivalence and Adhesion Assessment
This study evaluates the bioequivalence and adhesion performance of a test rivastigmine transdermal patch compared with the reference product, Exelon® Patch 10 (9.5 mg/24 h), in healthy adult volunteers of both sexes under…
- Trial name
- NCT07464340
- Testing
- Rivastigmine TDS 9,5 mg/24 h, Exelon® 9.5 mg/24 h
- Where
- Brazil
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Zodiac Produtos Farmaceuticos S.A.
Healthy
A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Non-Fasting Conditions
This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co.
- Trial name
- NCT01188057
- Testing
- ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG, NIRAVAM TM 2 mg orally disintegrating tablets, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Linagliptin Compared With the Free Combination of Empagliflozin Tablet and Linagliptin Tablet in Healthy Male and Female Subjects
The primary objective of this trial is to investigate the bioequivalence of one fixed dose combination tablet of empagliflozin/linagliptin (Test, T) compared with the free combination of one empagliflozin tablet and one…
- Trial name
- NCT02758171
- Testing
- Empagliflozin, Linagliptin
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Subjects
Dapagliflozin Tablet 10 mg Relative to Forxiga® Tablets 10 mg
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- DAP-030-23 (NCT06233045)
- Testing
- Dapagliflozin-Test product, Dapagliflozin-Reference product
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
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
Healthy
A Study of Lanabecestat (LY3314814) in Healthy Participants
The purpose of this study is to measure how much of a new tablet formulation of lanabecestat gets into the blood stream and how long it takes the body to get rid of it, compared to the current tablet formulation of lanabecestat.
- Trial name
- NCT02663128
- Testing
- Lanabecestat
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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