Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy Volunteer
A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants
This is a Phase I, open-label, randomized, four-treatment period, four-sequence, single-dose, crossover pharmacokinetic study to determine the bioequivalence of pirfenidone after administration of tablet and capsule dosage forms…
- Trial name
- NCT02525484
- Testing
- Pirfenidone
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Subjects in Fasted and Fed State
The Purpose of the Study is to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR in Healthy Subjects Under Fasting and Fed Conditions
This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet manufactured at two different plants.
- Trial name
- NCT03216278
- Testing
- Dapagliflozin/metformin XR 5/500mg, Dapagliflozin/metformin XR 5/500 mg, Dapagliflozin/metformin XR 10/1000mg
- Where
- Brazil
- Volunteers
- 284 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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 Volunteer
A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers
The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing under fed conditions.
- Trial name
- NCT01020136
- Testing
- AG-013736
- Where
- Singapore
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bioequivalance
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 100 mg/1000 mg in Healthy Subjects, Fed Study.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- ACL25-IC005 (NCT07763964)
- Testing
- Janumet XR, Sitagliptin/Metformin FDC
- Where
- Mexico
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- ADIUM
Healthy
Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil and hydrochlorothiazide 40 mg/25 mg tablets to Sankyo's Benicar HCT® 40 mg/25 mg tablets following a single, oral 40 mg/25 mg (1 x…
- Trial name
- NCT01020214
- Testing
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg, Benicar HCT® Tablets 40 mg/25 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Participants
Bioequivalence Study for Crizotinib Encapsulated Microsphere Formulation (eMS)
Bioequivalence study to evaluate the pharmacokinetics of a new crizotinib encapsulated microsphere (eMS) formulation
- Trial name
- NCT04856293
- Testing
- Crizotinib
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
T2DM (Type 2 Diabetes Mellitus)
Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets
This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test…
- Trial name
- NCT07412015
- Testing
- treatment T (dose 1), treatment T (dose 2), treatment R (dose 1)
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chipscreen Biosciences, Ltd.
Bioequivalance
Bioequivalence Study of EMPAGLIFLOZIN (25 mg Tablets) vs. JARDIANCE® (25 mg Tablets), in Healthy Research Subjects, Under Fasting Conditions
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
- Trial name
- EB-24-003 (NCT07479108)
- Testing
- Empagliflozin (Jardiance®), Empagliflozin (oral)
- Where
- Mexico
- Volunteers
- 32 people
- Sponsor
- ADIUM
Fasting
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fed Condition
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover, oral pivotal bioequivalence study.
- Trial name
- NCT01831687
- Testing
- Etodolac Extended Release Tablets USP 600mg, Etodolac Extended Release Tablets 600mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Fasting Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mg
The objective of this study was to investigate the bioequivalence of Mylan's alprazolam 3 mg Extended-release tablets to Pharmacia \& Upjohn's Xanax XR® 3 mg tablets following a single, oral 3 mg (1 x 3 mg) dose administered…
- Trial name
- NCT00647634
- Testing
- Alprazolam Extended-Release Tablets 3 mg, Xanax XR® Tablets (3 mg
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
The purpose of this study is to evaluate the relative bioavailability of nabumetone from 2 tablet products and determine if the 2 products were bioequivalent to each other.
- Trial name
- NCT00864968
- Testing
- Nabumetone 750 mg tablets, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy Volunteers
Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites
This study is an open-label, single-center, two-period, two-sequence crossover study to assess the bioequivalence of SP-01 (Sancuso®: Granisetron Patch) manufactured at two different sites.
- Trial name
- NCT05075876
- Testing
- SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron), SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)
- Where
- Hong Kong
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Solasia Pharma K.K.
Healthy Participants
Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition
This study is intended to establish bioequivalence of the bosutinib age-appropriate capsule formulation to the commercial tablet formulation in healthy participants under fed condition.
- Trial name
- NCT04549480
- Testing
- Bosutinib capsule, Bosutinib tablet
- Where
- 2 sites in Netherlands
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bioequivalence
Bioequivalence Study of Perindopril Tablets in Healthy Volunteers Under Fasting Conditions
This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Prestarium ® A 10 mg tablets) or the test (Perindopril 8 mg tablets)…
- Trial name
- NCT06213610
- Testing
- Perindopril tablet, Prestarium® A tablet
- Where
- Russia
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Fasting Study of Cilostazol Tablets 100 mg and Pletal® Tablets 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's cilostazol 100 mg tablets and Otsuka's Pletal® 100 mg tablets following a single, oral 100 mg(1 x 100 mg) dose administered under fasting conditions.
- Trial name
- NCT00648388
- Testing
- Cilostazol Tablets 100 mg, Pletal® Tablets 100 mg
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Breast Cancer, Breast Neoplasms
A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)
Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2).
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Disease, Antineoplastic Agents
- Trial name
- NCT06886659
- Testing
- Trastuzumab (proposed Trastuzumab biosimilar), Herclon
- Where
- 2 sites in Bangladesh
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Incepta Pharmaceuticals Ltd
Healthy
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to assess the bioequivalence between Atorvastatin calcium 40 mg of Dr. Reddy's Laboratories Limited, India and Lipitor® 40mg Tablets of Pfizer Ireland Pharmaceuticals in healthy, adult, human subjects…
- Trial name
- NCT01645410
- Testing
- Atorvastatin Calcium Tablets, 40 mg
- Where
- India
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Study Comparing Four Different Rivoceranib Tablets in Healthy Participants
The main purpose of this trial is to compare a single dose of 4 different rivoceranib tablets in healthy adult participants.
- Trial name
- NCT05287360
- Testing
- Rivoceranib
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Elevar Therapeutics
Therapeutic Equivalency
Bioequivalence Study in Healthy Subjects, 2*5 mg Tablets Rivaroxaban Versus 1*10 mg Tablet Rivaroxaban
The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or…
- Trial name
- NCT01436526
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Bayer
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