Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin Extended Release Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants
The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet coadministered with canagliflozin in healthy…
- Trial name
- NCT02851212
- Testing
- Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Canagliflozin, Metformin Extended Release (XR)
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent, Healthy Volunteers
A Study to Compare How Much of the Study Treatment Finerenone Gets Into the Blood When the Same Amount is Taken in One and in Two Tablets of Different Strengths in Healthy Male Participants
In this bioequivalence study, healthy male participants took the study treatment finerenone in the form of one and two tablets of different strengths by mouth.
- Trial name
- NCT07116512
- Testing
- Finerenone (BAY94-8862): intervention A, Finerenone (BAY94-8862): intervention B
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bayer
Bioequivalence
Bioequivalence Study of Favir 200 mg Film Tablet Kocak Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- NCT04444986
- Testing
- FAVIR 200 MG FT, AVIGAN 200 mg FT
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Kocak Farma
Migraine, Headache
Bioequivalence Study to Compare Ibuprofen/ Paracetamol Tablets (200mg Ibuprofen/ 500mg Paracetamol) Versus Nuromol® Tablets (200mg Ibuprofen/ 500mg Paracetamol)
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Ibuprofen/ Paracetamol tablets (200mg Ibuprofen/ 500mg Paracetamol) versus Nuromol® tablets (200mg Ibuprofen/ 500mg…
- Conditions
- Migraine, Headache, Backache
- Trial name
- NCT06180070
- Testing
- Ibuprofen/ Paracetamol tablets, Nuromol® tablets
- Where
- Jordan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Parkinson Disease
Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC)
This study evaluates the bioavailability and bioequivalence between two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage strengths (50 mg and 25 mg) after single and multiple dose…
- Trial name
- NCT04265027
- Testing
- 50 mg BIA 9 1067, 25 mg BIA9 1067, 50 mg Ongentys
- Where
- United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy Subjects
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to…
- Trial name
- B538-07 (NCT02237729)
- Testing
- PF-06410293, Adalimumab-US, Adalimumab-EU
- Where
- 8 sites in United States
- Volunteers
- 362 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pharmacokinetics
Fed Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers
This study was designed to compare the bioavailability of the Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono…
- Trial name
- NCT05125575
- Testing
- Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine), Glucophage® XR 1000 mg Prolonged Release Tablets
- Where
- Czechia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Healthy Participants
A Phase 1 Study of Navlimetostat Tablet Formulations
This study aims to compare the PK of Navlimetostat after administration of a wet-granulation tablet versus the dry-granulation tablet formulation in healthy adult female
- Trial name
- NCT07544628
- Testing
- Navlimetostat
- Where
- 4 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Volunteers
A Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations
The purpose of this study is to evaluate the relative bioavailability of Povetacicept formulations, bioequivalence of Povetacicept presentations, and safety and tolerability of Povetacicept.
- Trial name
- NCT07010406
- Testing
- Povetacicept
- Where
- 2 sites in United States
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Bioequivalence Study in Healthy Subjects
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 5 mg / 850 mg Tablets Under Fed Conditions.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL24-PC018 (NCT07633015)
- Testing
- Test. Empagliflozin/metformin 5/850 mg, Synjardy 5/850 mg tablet, Reference
- Where
- Mexico
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- ADIUM
Healthy
A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on an Empty Stomach in Healthy Subjects
In order to evaluate the bioequivalence of the test preparations and reference preparations of perindopril tert-butylamine tablets after meal and their safety in Chinese adult healthy subjects.
- Trial name
- NCT04556058
- Testing
- Perindopril tert-Butylamine tablets （ Produced by Haisco）, Perindopril tert-Butylamine tablets（ACERTIL®）
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
GERD
A Study to Compare PK, PD and Safety of CKD-381 in Healthy Subjects
A Study to compare Pharmacokinetics, Pharmacodynamics and safety of CKD-381 and D027 in healty subjects
- Trial name
- NCT03211143
- Testing
- CKD-381, Nexium
- Where
- South Korea
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
This is a bioequivalence study of nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited under fasting conditions
- Trial name
- NCT01161940
- Testing
- Nizatidine, Axid
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Fasting Study of Alprazolam Extended-Release Tablets 1 mg to Xanax XR Tablets 1 mg
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 1 mg Extended-release tablets to Pharmacia \& Upjohn's Xanax XR 1 mg tablets following a single, oral 3 mg (3 x 1 mg) dose administered under…
- Trial name
- NCT00647894
- Testing
- Alprazolam Extended-Release Tablets 1 mg, Xanax XR Tablets 1 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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
Bioequivalence
Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta
Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy…
- Trial name
- NCT03146988
- Testing
- RGB-02 or Neulasta® (pegfilgrastim)
- Where
- United Kingdom
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Gedeon Richter Plc.
Healthy Volunteers
Bioequivalence Study of Cyclosporine 100mg Capsule Under Fed Condition
To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference Product (B):Neoral (Cyclosporine…
- Trial name
- NCT01080586
- Testing
- Cyclosporine Capsules USP (Modified) 100 mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Healthy
Fasting Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg and Lopressor HCT® Tablets 100/50 mg
The objective of this study was to investigate the bioequivalence of Mylan metoprolol tartrate/hydrochlorothiazide 100/50 mg tablets to Novartis Lopressor HCT® 100/50 mg tablets following a single, oral 100/50 mg (1 x 100/50 mg)…
- Trial name
- NCT00649688
- Testing
- Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg, Lopressor HCT® Tablets 100/50 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Subjects (HS)
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508A and YHR2601 in healthy subjects
- Trial name
- NCT07912827
- Testing
- YHP2508A, YHR2601
- Where
- 2 sites in South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
To Determine the Bioequivalence Under Fasting Conditions
Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions
-To compare the single dose bioavailability of Kali and BTG
- Trial name
- NCT00652886
- Testing
- Oxandrolone, Oxandrin
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
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