Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy Subjects
Bioequivalence Study of SB797620 in Healthy Japanese Volunteers
This study will test whether the Drug levels in plasma after combination formulation tablet dosing (SB797620) and separate formulation tablets dosing (rosiglitazone and glimepiride) to Japanese Healthy volunteer would be the same…
- Trial name
- NCT00549263
- Testing
- SB797620
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed Conditions
Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets aventis Administered as 1 x 180 mg Tablet in Healthy Subjects under…
- Trial name
- NCT01066767
- Testing
- Fexofenadine
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Anaemia
Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants
This study is comprised of two discrete Parts. Part A is a 3-period cross over evaluating relative bioavailability. Part B is a 2-period cross over evaluating bioequivalence.
- Trial name
- NCT04640311
- Testing
- Daprodustat
- Where
- 4 sites in United States
- Volunteers
- 259 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Contraceptives, Postcoital
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg
A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods.
- Trial name
- LEVEQ-3 (NCT01073904)
- Testing
- Levonorgestrel Emergency Pill (BAY86-5028), Postinor 2
- Where
- Mexico
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers
A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants
The purpose of this study is to assess the bioequivalent effect of venglustat in tablet and hard capsule form when give with water under fasting conditions.
- Trial name
- NCT06418607
- Testing
- Venglustat
- Where
- 2 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Sanofi
Infections, Respiratory Tract
Bioequivalence Study of Cephalexin Suspension 250
The objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent. Test product was Ceporex® (250 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5…
- Trial name
- NCT01767571
- Testing
- Cephalexin 125 mg/5ml, Cephalexin 250mg/5ml
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Antidiarrheals
Bioequivalence Between a Racecadotril Capsule and Film-Coated Tablet (FCT) to Treat Diarrhea in Adults
This study is designed to assess bioequivalence between two products used for treatment of acute diarrhea.
- Trial name
- NCT01302093
- Testing
- Racecadotril Film-Coated Tablet (FCT), Racecadotril Capsule
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Gastritis
A Pilot Study to Determine the Relative Bioavailability of Mosapride 5mg From Two Candidate Formulations of GR107719B Relative to One 5mg Tablet of Reference Mosapride Citrate (GASMOTIN™) in Healthy Adult Human Subjects Under Fasting Conditions
This study aims to determine the relative bioavailability of two candidate formulations of mosapride citrate 5mg tablets compared the reference product GASMOTIN (mosapride citrate 5mg) from Dainippon Pharmaceutical Company in…
- Trial name
- NCT02201316
- Testing
- Reference mosapride citrate (GASMOTIN), GR107719B (Formulation 1), GR107719B (Formulation 2)
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood
2 different formulations and doses of tafamidis will be compared. All subjects will receive both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they will take tafamidis twice, 12 hours apart and…
- Trial name
- NCT03266705
- Testing
- tafamidis
- Where
- Belgium
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study of Cephalexin Liquid for Pediatrics in Healthy Adults 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
- NCT02123472
- Testing
- Cephalexin
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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
A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions
The purpose of this study is to evaluate the single-dose Pharmacokinetic (PK) and bioequivalence of darunavir (DRV) in the presence of cobicistat (COBI) when administered as a scored fixed dose combination (FDC) tablet (DRV/COBI)…
- Trial name
- NCT04718805
- Testing
- Darunavir, Cobicistat, Darunavir/Cobicistat FDC
- Where
- Belgium
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Pivotal Bioequivalence Study of Exemestane 25 mg Tablets Under Fasting Conditions in Healthy Subjects
The objective of this study is to assess the bioequivalence of the test product, Exemestane 25 mg tablets of Actavis Group PTC ehf.
- Trial name
- NCT01760980
- Testing
- Reference product (A) Aromasin (Exemestane), Test product (B) Exemestane
- Where
- South Africa
- Volunteers
- healthy volunteers welcome
- Sponsor
- Actavis Inc.
Pulmonary Arterial Hypertention
A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions
The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet…
- Trial name
- NCT01247805
- Testing
- sildenafil citrate
- Where
- Belgium
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Donepezil 10 mg Tablets Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption of donepezil 10 mg tablet (test) versus Aricept® (reference), administered as a 1 x 10 mg tablet under fasting conditions.
- Trial name
- NCT01439230
- Testing
- Donepezil, Aricept®
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence
The Bioequivalence Study of Umifenovir 200 mg Capsul (ATABAY, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg umifenovir hydrochloride monohydrate equivalent to 200 mg umifenovir hydrochloride and a single dose of Test product containing 200 mg umifenovir hydrochloride monohydrate…
- Trial name
- Umifenovir (NCT04476719)
- Testing
- ATAFENOVIR 200 MG KAPSUL, ARBIDOL 100 MG KAPSUL
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Atabay Kimya Sanayi Ticaret A.S.
Healthy
Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions.
- Trial name
- NCT00648219
- Testing
- Olmesartan Medoxomil Tablets 40 mg, Benicar® Tablets 40 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions
The objective of this study was to compare the relative bioavailability of Sumatriptan Succinate Tablets 100 mg with Imitrex Tablets 100 mg under fed conditions in healthy adult human subjects.
- Trial name
- NCT01269281
- Testing
- Sumatriptan
- Where
- India
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.
- Trial name
- NCT02028767
- Testing
- Empagliflozin 2.5 mg, Empagliflozin 10 mg, Metformin 500 mg
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Cefprozil 250 mg/ 5mL Powder For Oral Suspension Under Fasting Conditions
The study was conducted as a blinded, randomized, 3-way crossover study to compare the single-dose relative bioavailability of Cefprozil 250 mg/5 mL Oral suspension versus Cefzil TM Powder for Oral Suspension (250 mg/5 mL)…
- Trial name
- NCT00778557
- Testing
- CEFPROZIL FOR ORAL SUSPENSION USP 250 mg/ 5 mL
- Where
- Canada
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
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