Clinical trials: Bioequivalence Study in Healthy Subjects
Type2 Diabetes
Bioequivalence Study for Gemigliptin/Metformin 50/1000 mg and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.
[Objectives]Primary: To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab.
- Trial name
- NCT04050098
- Testing
- gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release, Gemigliptin tartrate sesquihydrate and metformin
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Chem
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 of Simvastatin Tablets 80 mg of Dr. Reddy's Under Fasting Condition
The purpose of this study is to compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg tablets of MercK \& Co.
- Trial name
- NCT01167894
- Testing
- Simvastatin
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healhty
Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg
The objective of this study was to investigate the bioequivalence of Mylan amlodipine and benazepril HCl 10 mg/20 mg to Novartis Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10 mg/20 mg) dose…
- Trial name
- NCT00649402
- Testing
- Amlodipine and Benazepril HCl Capsules 10 mg/20 mg, Lotrel® Capsules 10 mg/20 mg
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01691456
- Testing
- Montelukast sodium
- Where
- India
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Hyperuricemia
Bioequivalence Study of 2 Sizes of SHR4640 Tablets Orally in Healthy Subjects
The study is being conducted to evaluate the pharmacokinetic, and safety of two sizes of SHR4640 tablets in healthy adults, to explore the bioequivalence between two sizes of SHR4640 tablets.
- Trial name
- NCT06168929
- Testing
- SHR4640
- Where
- China
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Drug Use
Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers
This study was conducted to investigate whether 100 mg/5 mL cefixime trihydrate dry syrup manufactured by PT. Bernofarm, Indonesia was bioequivalent to its reference product, 100 mg/5 mL Suprax® dry syrup manufactured by Odan…
- Trial name
- NCT04982861
- Testing
- Cefixime Trihydrate 100 mg/5 mL Dry Syrup, Suprax 100 MG in 5 mL Oral Suspension
- Where
- Indonesia
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- PT Bernofarm
Healthy Volunteers
Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.
- Trial name
- NCT01055769
- Testing
- Linezolid
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual…
- Trial name
- NCT03629054
- Testing
- Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination), Empagliflozin, Linagliptin
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers
This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.
- Trial name
- NCT00658554
- Testing
- ARQ 197
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Female Contraception, Contraception
Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.
The purpose of the study is to determine the bioequivalence of NGM and EE in 2 formulations of 250 mcg NGM/35 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid.
- Conditions
- Female Contraception, Contraception, Therapeutic Equivalency, Pharmacokinetics
- Trial name
- NCT00709189
- Testing
- Norgestimate/Ehinyl Estradiol; Folic acid.
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects, Under Fed Conditions
Objective: To assess the bioequivalence of Lamotrigine 2 x 25 mg IR tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of Glaxo-SmithKline, USA, in healthy human adult subjects…
- Trial name
- NCT00939458
- Testing
- Lamotrigine
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Rhinitis
Bioequivalence Study Between Levocetirizine Oral Disintegrating Tablet (ODT) and Levocetirizine Immediate Release Tablet (IRT)
This study will be an open-label, randomized 2-way cross-over study to evaluate bioequivalence study between levocetirizine ODT and levocetirizine IRT in healthy Japanese male subjects.
- Trial name
- NCT03555890
- Testing
- Levocetirizine IRT 5 mg, Levocetirizine ODT 5 mg
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Subjects (HS)
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508B and YHR2602 in healthy subjects.
- Trial name
- NCT07912840
- Testing
- YHP2508B, YHR2602
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Drug Use
Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject
The study was conducted to investigate whether 20 mg omeprazole capsules manufactured by PT. Dankos Farma for PT. Hexpharm Jaya is bioequivalent to its reference product, 20 mg Losec® capsules manufactured by AstraZeneca AB…
- Trial name
- NCT05849883
- Testing
- Omeprazole 20 mg Capsules
- Where
- Indonesia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- PT Kalbe Farma Tbk
Healthy Participants
Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition
This study is intended to establish bioequivalence of the bosutinib age-appropriate capsule formulation to the commercial tablet formulation in healthy participants under fed condition.
- Trial name
- NCT04549480
- Testing
- Bosutinib capsule, Bosutinib tablet
- Where
- 2 sites in Netherlands
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bioequivalence
A Study Comparing Two Different Capsules, APL-101 and PLB-1001 Capsules, in Healthy Chinese and Caucasian Participants
This is a Phase 1, open-label, multi-center, randomized, 2-period, adaptive design, crossover study to assess the bioequivalence of APL-101 (Vebreltinib) capsules and PLB-1001 (Bozitinib) capsules.
- Trial name
- NCT05367388
- Testing
- APL-101, PLB-1001
- Where
- New Zealand
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Apollomics Inc.
Healthy
Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145
To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145
- Trial name
- NCT02307461
- Testing
- IPI-145 (duvelisib), IPI-145
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- SecuraBio
Healthy Volunteers
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation Of Myrin P Forte That Contains Rifampicin, Isoniazid, Ethambutol And Pyrazinamide Per Tablet To An Equivalent Dose Of Single Drug Reference Preparations Of Similar Combination Following Oral Administration In Healthy Adults
This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against reference drug in healthy volunteers.
- Trial name
- NCT01399788
- Testing
- Myrin P Forte, Single drug references
- Where
- Singapore
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study of Dr. Reddys Under Fed Conditions
Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study of Dr. Reddys Under Fed Conditions
- Trial name
- NCT01064180
- Testing
- Carvedilol
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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