Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study on a Olostar Tab Versus Two Co-administered Reference Products Olmesartan Medoxomil and Rosuvastatin Calcium in Healthy Volunteers
To demonstrate the bioequivalence of a Olostar Tab versus two co-administered reference IMPs Olmetec and Crestor.
- Trial name
- NCT02561884
- Testing
- Olostar Tab., Co-administration of Olmetec and Crestor
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy Volunteers
A Study of Cephalexin in Healthy Participants
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods.
- Trial name
- NCT02100826
- Testing
- Cephalexin
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Diabetes Mellitus
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.
The purpose of this study is the comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers under the conditions of…
- Trial name
- NCT00596063
- Testing
- Wosulin R, Novolin R
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Healthy
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fasting Conditions
The purpose of this study is To compare the single oral dose bioavailability of test product, Trandolapril 4 mg Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult, human subjects, under fed…
- Trial name
- NCT01164787
- Testing
- Trandolapril, Mavik
- Where
- India
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus)
Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components
A Study to Assess the Bioequivalence of the fixed dose combination (FDC) of Dapagliflozin and Sitagliptin, and Dapagliflozin 10 mg and Sitagliptin 100 mg administered as individual tablets in Healthy Subject
- Trial name
- NCT05266404
- Testing
- Dapagliflozin/sitagliptin FDC, Sitagliptin, Dapagliflozin
- Where
- Germany
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Study in Healthy People to Compare Two Different Sifrol® Tablets
The main objective of this trial is to establish the bioequivalence of Sifrol® tablets manufactured at two different sites.
- Trial name
- NCT06457204
- Testing
- Pramipexole manufactured in Ingelheim, Pramipexole manufactured in Ennigerloh
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 25 mg and MET XR 1,000 mg) in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.
- Trial name
- NCT05363384
- Testing
- CT-L01, Alogliptin Benzoate 25 mg, Metformin HCl XR 1,000 mg
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Celltrion
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
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
Healthy Adult
A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males
The purpose of this study is to investigate the bioequivalence of improved and current orally disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each of two administration methods…
- Trial name
- NCT01506752
- Testing
- Donepezil Hydrochloride
- Where
- Japan
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Bioequivalence, Safety
Oral Bio-equivalence Study
Title of Study: An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period, Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules (3 x 0.5 mg) in Healthy Adult Human Subjects…
- Trial name
- NCT05145621
- Testing
- Fingolimod 0.5 mg capsules- Test drug
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Alembic Pharmaceuticals Ltd.
Viral Infection COVID-19
Pharmacokinetics and Bioequivalence of Aterixen 100 mg Tablets and Aterixen 100 mg Film-coated Tablets in Healthy Volunteers
1. Comparative evaluation of the safety of the drug Aterixen 100 mg tablets (Valenta Pharm JSC, Russia) and Aterixen 100 mg film-coated tablets (Valenta Pharm JSC, Russia) administered in single doses under fasting conditions in…
- Trial name
- NCT06096571
- Testing
- Aterixen
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Healthy
A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of an intravenous (IV) administration of the guselkumab formulation using UltraSafe Plus Passive Needle Guard (PFS-U) to create the IV solution versus the guselkumab…
- Trial name
- NCT04617691
- Testing
- Guselkumab
- Where
- Germany
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatitis B
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg…
- Trial name
- NCT01427868
- Testing
- LB80380 maleate salt, LB80380 free base
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy
Fed Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg
The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.
- Trial name
- NCT00650013
- Testing
- Midodrine HCl Tablets 5 mg, ProAmatine® Tablets 5 mg
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Loratadine Orally Disintegrating Tablets 10 mg Under Fed Conditions
To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating tablets of Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, Inc.
- Trial name
- NCT00776282
- Testing
- loratadine 10 mg orally disintegrating
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Bacterial Infections
Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule
To assess the relative bioavailability of two different batches of Frademicina® drug product, containing 500 mg lincomycin hydrocloride, manufactured by Pfizer Laboratories Ltd.
- Trial name
- NCT01058824
- Testing
- Lincomycin
- Where
- 2 sites in Brazil
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of Propranolol Under Fasting Conditions
To compare the single-dose bioavailability of Propranolol 160 Mg ER capsules with Inderal-La
- Trial name
- NCT00653120
- Testing
- Propranolol, Inderal-LA
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy Participants
A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants
The purpose of the study is to assess the bioequivalence of olezarsen between 2 subcutaneous (SC) formulations [(autoinjector (AI) and vial] at 2 dose levels in healthy adult participants.
- Trial name
- NCT05579860
- Testing
- Olezarsen
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Healthy
Bioequivalence Study of Propofol Medium and Long Chain Fat Emulsion Injection in Healthy Chinese Subjects
This study assessed the bioequivalence and safety of a single dose of Propofol Medium/Long Chain Fat Emulsion Injection (Test product, Haisco Pharmaceutical Group Co., Ltd.) compared to the reference product (Propofol Medium/Long…
- Trial name
- NCT07057609
- Testing
- Tested Propofol Medium and Long Chain Fat Emulsion Injection (T), Reference Propofol Medium and Long Chain Fat Emulsion Injection (R)
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
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