Clinical trials: Bioequivalence Study in Healthy Subjects
Epilepsy
Bioequivalence of Two Different Sources of Eslicarbazepine Acetate
The purpose of this study is to determine whether the test product, eslicarbazepine acetate 800 mg tablets (test 1, To be marketed (TBM) Treatment A), and the reference product, eslicarbazepine acetate 800 mg tablets (current…
- Trial name
- NCT03116321
- Testing
- Eslicarbazepine acetate (ESL)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Diabetic Foot
BE Study of Metformin GSK 850mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition.
- Trial name
- BA/BE 198/11 (NCT01710540)
- Testing
- Metformin GSK 850mg, Gluocophage 850mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Anxiety Disorders
Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
This study will be conducted to evaluate and compare the single oral dose bioavailability of Paroxetine manufactured by GlaxoSmithKline (GSK) Pharmaceuticals S.A. for GlaxoSmithKline México, S.A. de C.V.
- Trial name
- NCT04311463
- Testing
- Paroxetine hydrochloride, PAXIL (Paroxetine hydrochloride )
- Where
- Mexico
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Clarithromycin 500mg Tablets Under Fasting Conditions.
The objective of this study is to compare the relative bioavailability of clarithromycin 500 mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy, adult subjects under fasting conditions.
- Trial name
- NCT00774644
- Testing
- Clarithromycin 500mg
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Fasting State
Bioequivalence Study of Allopurinol 300 mg Tablets USP Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over comparative pivotal study.
- Trial name
- NCT01603134
- Testing
- Allopurinol
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy Subjects
Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets
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
- NCT06289881
- Testing
- Sildenafill-Test product, Sildenafill-Reference product
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy Volunteers
Bioequivalence Study of CJ-30059
This study is designed to evaluate the bioequivalence of the two treatments, the administration of CJ-30059 and the co-administration of candesartan cilexetil and amlodipine besylate, in healthy volunteers.
- Trial name
- CCA (NCT02173912)
- Testing
- Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference), CJ-30059 (Test)
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Healthy
Bioequivalence Study of Torrent Pharmaceutical Limited's Venlafaxine Hydrochloride ER Capsules Under Fed Conditions
Objective: The Bioequivalence studies were performed to compare the rate and extent of release of the drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride Extended-Release Capsules 150mg of…
- Trial name
- NCT01418612
- Testing
- Venlafaxine Hydrochloride Extended-Release Capsules of Torrent Pharmaceuticals Limited
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fed Conditions
This open-label, balanced, randomized, two-treatment, four-period, two-sequence, single dose, crossover fully replicated study was conducted on fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets of…
- Trial name
- NCT00872235
- Testing
- fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
- Trial name
- NCT01119443
- Testing
- PPX ER
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study
The purpose of this study is to assess bioequivalence between metformin hydrochloride (Glucophage® XR) manufactured in PT Merck Tbk, Indonesia (test drug) and metformin hydrochloride (Glucophage® XR) manufactured in Merck Santé…
- Trial name
- NCT03583385
- Testing
- Glucophage XR (Test drug), Glucophage XR (Comparator drug)
- Where
- Indonesia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects
The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MSB11455 and Neulasta in healthy adult subjects.
- Trial name
- NCT03251248
- Testing
- MSB11455, Neulasta
- Where
- 2 sites in Australia
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Healthy
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed Condition
This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01511718
- Testing
- Ondansetron Hydrochloride
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet
This is a healthy volunteers study to assess the bioequivalence of vadadustat 450 mg tablets (Test A) compared to three 150mg tablets (Reference B).
- Trial name
- NCT03657290
- Testing
- vadadustat
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Healthy
Bioequivalence Study of Fluoxetine HCL 40 mg Capsules Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of fluoxetine HCL 40 mg capsules (by Ranbaxy Laboratories Limited) with that of PROZAC® 40 mg capsules (by Dista Products Company) following a single oral…
- Trial name
- NCT00778024
- Testing
- fluoxetine HCL 40 mg capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Bioequivalence
Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting Conditions
This single dose study is designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the comparative bioavailability of fluconazole in the two formulations in healthy…
- Trial name
- NCT04038008
- Testing
- Fluconazole, Diflucan®
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy Subjects
A Study 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
- NCT07235189
- Testing
- Bempedoic acid, Ezetimibe, Atorvastatin
- Where
- Portugal
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Fasting
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fasting Condition
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover, oral pivotal bioequivalence study.
- Trial name
- NCT01827865
- Testing
- Etodolac Extended Release Tablets USP 600mg, Etodolac Extended Release Tablets 600mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy Adults
A Bioequivalence Study of Two Formulations Lamotrigine 100 mg Tablets and Lamictal 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions
This is an open-labeled, randomized, crossover, two-period, single-center, comparative study, where each participant will be randomly assigned to the reference (Lamictal, 100 mg tablets) or the test (Lamotrigine, 100 mg tablets)…
- Trial name
- NCT03898011
- Testing
- Lamotrigine, Lamictal
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Bioequivalence Study of Galantamine 4 mg Tablet and Reminyl Following a 4 mg Dose in Healthy Subjects Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of Purepac, a subsidiary of Alpharma Inc., U.S.A., galantamine and Janssen Pharmaceutica Products, L.P., U.S.A.
- Trial name
- NCT01190761
- Testing
- Galantamine 4 mg Tablet, single dose, Reminyl 4 mg Tablet, single dose
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
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