Clinical trials: Bioequivalence Study in Healthy Subjects
- Condition Bioequivalence Study in Healthy Subjects
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Healthy
A Study of Canagliflozin and Metformin Immediate Release (150 mg/500 mg) FDC Tablets in Healthy Volunteers
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets…
- Trial name
- NCT01508182
- Testing
- Canagliflozin tablets, Metformin IR tablets, Canagliflozin/metformin IR FDC tablets
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Topiramate 25 mg Capsule Mixed With Applesauce Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption or topiramate 25 mg capsules (test) versus Topamax® (reference) administered as the content of 2 x 25 mg capsules mixed with applesauce under fasting…
- Trial name
- NCT00905346
- Testing
- Topiramate 25 mg Capsules, Topamax® 25 mg Capsules, Applesauce
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Type II Diabetes
A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets.
- Trial name
- NCT05108350
- Testing
- T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR, T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
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
Fasting
Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fasting Condition
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01735370
- Testing
- Etodolac Tablets USP 500mg, Etodolac Tablets USP 500 mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants
The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current commercial abiraterone acetate uncoated…
- Trial name
- NCT02230046
- Testing
- Abiraterone acetate (Treatment A), Abiraterone acetate (Treatment B)
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block
The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block.
- Trial name
- NCT02466503
- Testing
- Fluticasone propionate, Salmeterol (as xinafoate)
- Where
- Taiwan
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Intech Biopharm Ltd.
Healthy Subjects
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
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
- NCT06233162
- Testing
- Febuxostat-Test product, Febuxostat-Reference product
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the Body
The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R) following a single oral dose administration.
- Trial name
- NCT06408870
- Testing
- BI 1015550
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Type 2 Diabetes Mellitus
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin IR tablet co-administered to…
- Trial name
- NCT00899470
- Testing
- Co-administration of Saxagliptin and Metformin IR, Fasted, Saxagliptin/Metformin, Fasting, Co-administration of Saxagliptin and Metformin IR, Fed
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
The objective of this study was to investigate the bioequivalence of Mylan nitrofurantoin monohydrate/macrocrystals capsules to Procter \& Gamble Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed…
- Trial name
- NCT01018342
- Testing
- Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg, Macrobid® Capsules 100 mg
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence
Clinical Study to Determine Bioequivalence of Oral Tamsulosin Products as 0.4 mg Prolonged-release Tablets in Male Subjects Under Fed Conditions
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x4, replicated, two treatments, four periods, two sequences controlled clinical study
- Trial name
- ACL25-PC007 (NCT07698288)
- Testing
- Tamsulosin 0.4 mg ER tablet
- Where
- Mexico
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- ADIUM
Bioequivalence
The Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil After a Single Oral Dose Administration Under Fasting Conditions.
This single dose study is designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of olmesartan in the two formulations in healthy subjects.
- Trial name
- NCT03951051
- Testing
- Olmesartan Medoxomil 40 mg, Olmetec®
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Type2diabetes
Bioequivalence Study to Compare Empagliflozin/ Metformin HCl 12.5mg/1000mg Film-coated Tablets
Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Empagliflozin/ Metformin HCl 12.5mg/1000mg film-coated tablets (12.5mg Empagliflozin / 1000mg Metformin HCl) versus…
- Trial name
- NCT06450262
- Testing
- Emapgliflozin/Metformin 12.5mg/1000mg Film-coated tablets, Synjardy® 12.5mg/1000mg film-coated tablets
- Where
- Jordan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
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)
Healthy
A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector compared to mirikizumab (reference) solution…
- Trial name
- NCT05515601
- Testing
- Mirikizumab
- Where
- 6 sites in United States
- Volunteers
- 396 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Bioequivalence
A Pilot Bioequivalence Study of Pomalidomide
Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.
- Trial name
- NCT03424928
- Testing
- Pomalidomide 4 MG Oral Capsule, Pomalidomide 4 MG Oral Capsule-Pomalyst
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy Volunteers
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.
- Trial name
- NCT02014272
- Testing
- RIN 150, reference drugs
- Where
- Singapore
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence Study of Levothyroxine Sodium Tablets 100 mcg
The objective of this study is to establish the bioequivalence of two levothyroxine formulations through the estimation of T4 levels in serum samples after baseline correction, according to Food and Drugs Administration (FDA)…
- Trial name
- NCT04573907
- Testing
- Drug Levothyroxine 100 mcg, Drug Eutirox 100 mcg
- Where
- Argentina
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Tecnoquimicas
Healthy
Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fasting…
- Trial name
- NCT00648466
- Testing
- Sumatriptan Succinate Tablets 100 mg, Imitrex® Tablets 100 mg
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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