Clinical trials: Bioequivalence Study in Healthy Subjects
Bioequivalence
A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade (BREATH-PK250-CC)
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT03894280
- Testing
- Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals, SERETIDE DISKUS® 250/50 inhalation powder/GSK, Activated Charcoal suspension
- Where
- Greece
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
Bioequivalence Study of UHAC 62 XX Tablets Compared With Capsules in Healthy Volunteers
Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) in fasted state.
- Trial name
- NCT02180490
- Testing
- UHAC 62 XX tablet, UHAC 62 XX capsule
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Asthma
Bioequivalence Study of Montelukast 10 mg Tablets
The objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent. Test product was Montelukast (10 mg tablets; GlaxoSmithKline) and reference product Singulair (10 mg tablets; Merck Sharp \&…
- Trial name
- NCT01943942
- Testing
- Montelukast 10 mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Food Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under…
- Trial name
- NCT00649259
- Testing
- Oxybutynin Chloride ER Tablets 10 mg, Ditropan XL® Tablets 10 mg
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fasting Condition
The objectives of this study are: To compare the single dose bioavailability of Metformin Hydrochloride 1000 mg tablets (Dr. Reddy's Laboratories Ltd., Generics, India) with Glucophage (Metformin Hydrochloride) 1000 mg tablets…
- Trial name
- NCT01160042
- Testing
- Metformin, Glucophage
- Where
- India
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Migraine
Bioequivalence of Two Tablet Forms of MK0974 (0974-045)
This study will evaluate the bioequivalence of two solid dose formulations of MK0974.
- Trial name
- NCT00965887
- Testing
- MK0974 Ethanolate formulation, Comparator: MK0974 Hydrate formulation
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolaemia
Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets
Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions.
- Trial name
- NCT07170852
- Testing
- Bempedoic acid film coated tablet, Nilemdo® Film-coated tablets
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Chronic Hepatitis B in Adults and Paediatric Patients
Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose, fully replicate, bioequivalence study in normal, healthy…
- Trial name
- NCT06592300
- Testing
- Tenofovir Alafenamide Film coated Tablet, Vemlidy® film-coated tablets
- Where
- India
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence of Vildagliptin Tablet Manufactured in China Compared to Imported Vildagliptin Tablet in Chinese Healthy Volunteers
This study will evaluate the bioequivalence as well as rate and extent of absorption of vildagliptin tablet manufactured by Beijing Novartis Pharma Ltd. compared to the imported vildagliptin tablet in Chinese healthy volunteers.
- Trial name
- NCT00414947
- Testing
- Vildagliptin (LAF237)
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novartis
Healthy Subject
Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers
- Trial name
- NCT06920719
- Testing
- YHP2406, YHR2501
- Where
- South Korea
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Healthy
A Study In Healthy Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of Three Formulations Of PH-797804
There is no difference in the rate and extent of absorption of the material sparing tablet (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3 formulation without SLS.
- Trial name
- NCT01226693
- Testing
- PH-797804 material sparing tablet, PH-797804 Phase2b/3 with sodium lauryl sulphate, PH-797804 Phase2b/3 without sodium lauryl sulphate
- Where
- Singapore
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Fed Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg
The objective of this study was to investigate the bioequivalence of Mylan's albuterol sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fed…
- Trial name
- NCT00649987
- Testing
- Albuterol Sulfate Extended-Release Tablets 8 mg, VoSpire® ER Tablets 8 mg
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Therapeutic Equivalency
Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets
The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets) in adult subjects under fasting…
- Trial name
- NCT00685165
- Testing
- Primidone 50 mg Tablet, Primidone (Mysoline®) 50 mg Tablet
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fed Conditions
The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other.
- Trial name
- NCT01665209
- Testing
- Morphine Sulfate
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Inc.
Major Depressive Disorder (MDD)
Single Dose Oral Bioequivalence Study of Vortioxetine Hemihydrobromide Orally Disintegrating Tablets
An open label, randomized, three-period, three-treatment [Treatment A (test product administered without water), Treatment B (test product administered with water) and Treatment C (Reference product administered with water)]…
- Trial name
- NCT05417087
- Testing
- Vortioxetine Hemihydrobromide Orally Disintegrating Tablets, Vortioxetine Hydrobromide Tablets
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seasons Biotechnology (Taizhou) Co., Ltd.
Healthy
A Relative Bioavailability Study of Carvedilol 12.5 mg Tablets Under Non-fasting Conditions
To compare the rate and extent of absorption of carvedilol from a test formulation of Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fed conditions.
- Trial name
- NCT00864149
- Testing
- Carvedilol 12.5 mg Tablets, single dose, Coreg® 12.5 mg Tablets , single dose
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Contraception, Contraception, Postcoital
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods.
- Trial name
- LEVEQ-1 (NCT01096485)
- Testing
- Levonorgestrel Emergency Pill (BAY86-5028/Opxion), Levonorgestrel (Postday)
- Where
- Mexico
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Epilepsy
Bioequivalence Study of 300 mg Gabapentin
The objective of this study was to confirm if two formulations of gabapentin (capsules) are bioequivalent. Test product was Darbetin® 300 mg (Laboratorios Dermatológicos Darier) and reference product Nerotin® 300 mg (Pfizer).
- Trial name
- NCT01738893
- Testing
- Gabapentin 300 mg
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects
The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese healthy male subjects.
- Trial name
- NCT01415778
- Testing
- ICI176,334-1, Casodex 80 mg tablet
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers
The hypothesis of this study is that one 5 mg tablet of axitinib has similar drug concentrations in plasma compared to five 1 mg tablets of axitinib after oral dosing.
- Trial name
- NCT00905814
- Testing
- AG-013736, AG-103736
- Where
- Singapore
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pfizer
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