Clinical trials: Therapeutic Equivalency
Healthy
Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions
This is an open label, randomised, 2-way crossover, comparative bioequivalence study.
- Trial name
- NCT01506791
- Testing
- Desloratadine and pseudoephedrine
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence of Telmisartan as Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination Tablet or as Two Telmisartan 40 mg Tablets in Healthy Male Volunteers
To establish bioequivalence of telmisartan orally administrated in two different ways: either with a telmisartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg fixed-dose combination tablet or with two telmisartan 40 mg tablets
- Trial name
- NCT02276391
- Testing
- Telmisartan/HCTZ combination, Telmisartan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to assess the bioavailability of Primidone 50 mg tablets of Dr.Reddy's comparing with that of Mysoline@ tablets of Yamanouchi Pharma Technologies Inc, in healthy, adult, human subjects under fasting…
- Trial name
- NCT01132040
- Testing
- Primidone
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Food Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administered…
- Trial name
- NCT00648076
- Testing
- Divalproex Sodium Extended-Release Tablets 500 mg, Depakote ER® Tablets 500 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Subjects
Nebivolol Tablets 5 mg Relative to Nebilet Tablets 5 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
- NCT06248099
- Testing
- Nebivolol-Test product, Nebivolol-Reference product
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Bioequivalence Study of Quetiapine Fumarate Tablets 300 mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, multicentric experimental bioequivalence study.
- Trial name
- NCT01566487
- Testing
- Quetiapine fumarate
- Where
- India
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of Zolpidem tartrate 10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT00833521
- Testing
- Zolpidem 10 mg tablets, AMBIEN® 10 mg tablets
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalance
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 50 mg/1000 mg in Healthy Subjects, Fast Study.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study.
- Trial name
- ACL25-IC002 (NCT07763899)
- Testing
- Sitagliptin/Metformin FDC, Janumet XR
- Where
- Mexico
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- ADIUM
Japanese Healthy Adult Male
A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet
The purpose of this study is to evaluate the BE of single oral dose of TAK-438 OD 20 milligram (mg) tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg…
- Trial name
- NCT03808493
- Testing
- TAK-438 OD, TAK-438
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Takeda
Breast Cancer
Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer
This study was a multicenter, randomized, open, single-dose, two-cycle, two-cross-dosing human bioequivalence trial designed to evaluate the bioequivalence of tested and reference preparations in breast cancer subjects.
- Trial name
- NCT06765590
- Testing
- T, 260 mg/m2, paclitaxel for injection (albumin-bound), R, 260 mg/m2, paclitaxel for injection (albumin bound).
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Diabetes Mellitus Type 2
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)
Empagliflozin and metformin hydrochloride are two separate drugs. The combination of these two drugs in one tablet are used for the treatment of type 2 diabetes, along with diet and exercise, and can be used with other drugs, if…
- Trial name
- NCT06792968
- Testing
- Empagliflozin + Metformin hydrochloride 5 mg/1000 mg combination film-coated tablets, Synjardy 5 mg/1000 mg film-coated tablets
- Where
- Russia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Gedeon Richter Plc.
Healthy Subjects
Bioequivalence Study of CJ-30060 in Healthy Volunteers
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor® 10mg in healthy volunteers.
- Trial name
- NCT03757390
- Testing
- Exforge® tab 5/160mg, Crestor® tab 10mg, CJ-30060 5/160/10mg
- Where
- South Korea
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Drug Use
Bioequivalence Study of Furosemide 40 mg Tablet in 24 Indonesian Healthy Volunteers
The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet manufactured by PT. Aventis Pharma, Indonesia.
- Trial name
- NCT04982874
- Testing
- Furosemide 40 mg, Lasix® 40 mg Tablet
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PT. Kimia Farma (Persero) Tbk
Healthy Adult Volunteers
Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.
This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers.
- Trial name
- NCT05162274
- Testing
- Lazertinib(G001), Lazertinib(G002)
- Where
- South Korea
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Bioequivalence
Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage® Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions
Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Long Merck )
- Trial name
- NCT03452306
- Testing
- Metformine, Glucophage® Long, Metformin
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Geropharm
Healthy Smokers
Nicotine Patch Bioequivalence Study
The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation.
- Trial name
- NCT01658202
- Testing
- V0116 transdermal patch (Test treatment ), Nicotine transdermal patch (Reference Treatment )
- Where
- France
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Hypertension
Bioavailability Study of Candesartan Cilexetil 16mg Tablet Under Fasting Conditions
This will be an open-label, randomized, single dose, two-way crossover study. Each subject will participate in both treatment periods and will receive single oral doses of candesartan cilexetil (GW615775) and reference…
- Trial name
- NCT02006602
- Testing
- Candesartan cilexetil (GW615775, Test formulation), Candesartan cilexetil (Reference treatment)
- Where
- India
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bioequivalence
Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Trial name
- NCT06830954
- Testing
- Group A, Reference Group
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Healthy
A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase I study to evaluate the safety and pharmacokinetics after co-administration of CTL0201 and CTL0202 or administration of CT-L02 in healthy volunteers.
- Trial name
- NCT07128654
- Testing
- CTL02, CTL0201, CTL0202
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Celltrion
Healthy
Famciclovir 500 mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under fasting conditions.
- Trial name
- NCT00834431
- Testing
- Famciclovir 500 mg Tablets, Famvir® 500 mg Tablets
- Where
- 2 sites in United States, Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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