Clinical trials: Fasting Conditions
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
Bioequivalence
Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions
This Study will investigate the bioavailability in fasting subjects of 1 capsule formulation containing Duloxetine 60 mg. The Study will be performed at a single site with 36 subjects.
- Trial name
- NCT04723238
- Testing
- Duloxetine 60mg Test Drug Enteric Coated Granules, Duloxetine 60mg Reference Product Enteric Coated Granules
- Where
- Chile
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Laboratorios Andromaco S.A.
Healthy Adults
Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, single-center, single-dose, crossover, in two periods and in two sequences comparative study, where each participant is randomly assigned to the reference or the test formulation in each period…
- Trial name
- NCT03898193
- Testing
- Montelukast, Singulair
- Where
- Russia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting Conditions
The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with…
- Trial name
- NCT00830206
- Testing
- Azithromycin, Zithromax®
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Seizures, Epilepsy
Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions
The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg…
- Trial name
- NCT00616681
- Testing
- Oxcarbazepine
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Healthy
Bioequivalence Study Between "Dong-A Atorvastatin Tab" and "Lipitor Tab"
An Open-Label, Randomized, 2-sequence, 4-period, Fasting Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence between "Dong-A Atorvastatin 80mg Tab" and "Lipitor 80mg Tab" in Healthy Volunteers
- Trial name
- NCT04325009
- Testing
- Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab, Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions
The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under fasting conditions.
- Trial name
- NCT01155895
- Testing
- Amlodipine Besylate / Benazepril Hydrochloride
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioavailability
A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions
The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine between the test (investigational medicinal product [IMP]) and reference products that could impact the bioavailability…
- Trial name
- NCT03905564
- Testing
- doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg combination, Diclegis (Registered Trademark)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Healthy Participants
A Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants Under Fasting Conditions
A Single-Center, Randomized, Single-Blind, Single-Dose, Parallel-Group Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants under…
- Trial name
- NCT07147257
- Testing
- CHS-1420, HUMIRA®
- Where
- China
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
Breast Cancer
Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions
- Trial name
- NCT01331421
- Testing
- exemestane
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Healthy
Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fasting Conditions
The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fasting conditions.
- Trial name
- NCT01155947
- Testing
- Anastrozole
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalance
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Sitagliptin/Metformin in Prolonged-release Tablets With 50 mg/1000 mg in Healthy Subjects, Fast Study.
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study.
- Trial name
- ACL25-IC002 (NCT07763899)
- Testing
- Sitagliptin/Metformin FDC, Janumet XR
- Where
- Mexico
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- ADIUM
Healthy
Bioequivalence Study of Ondansetron Orally Disintegrating Tablets 8mg Under Fasting Conditions
The purpose of this study is to compare the single-dose oral bioavailability of Ondansetron 8 mg orally disintegrating tablets of OHM Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc, USA) with Zofran ODT® 8 mg…
- Trial name
- NCT01523093
- Testing
- Ondansetron
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Type 2 Diabetes
Study to Compare the Bioavailability of Extended Release Metformin HCl Tablet Versus Glucophage XR® Tablets in Healthy Human Volunteers Under Fasting Condition
Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference formulation, Bristol-Myers Squibb Company, USA) in…
- Trial name
- NCT01089166
- Testing
- Metformin
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Fasting
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fasting Condition
The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fasting conditions and to monitor adverse events and ensure safety of subjects.
- Trial name
- NCT01503437
- Testing
- Olanzapine OD Tablets 5 mg
- Where
- India
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Anxiety Disorders
Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) and paroxetine IR tablets have been approved for the treatment of three anxiety indications in China.
- Trial name
- NCT03329573
- Testing
- Paroxetine IR tablets A, Paroxetine IR tablets B
- Where
- China
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare the rate and extent of absorption of ranitidine 300 mg tablets versus Zantac 300 mg tablets administered as 1 x 300 mg tablet under fasting conditions.
- Trial name
- NCT01131702
- Testing
- Ranitidine
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers
Bioequivalence Study With Pharmacokinetic Endpoints, Comparing a Single Dose of Iron Sucrose Azad Injection of Azad Pharma Corporation (AG), With a Single Dose of Venofer® Injection of Vifor Corporation (AG) in Healthy Adult Volunteers
A Clinical Trial to Demonstrate the Comparability of the Two Iron Sucrose Injection Solutions Iron Sucrose Azad of Azad Pharma AG and Venofer® of Vifor Pharma AG.
- Trial name
- NCT02391181
- Testing
- Iron Sucrose Azad, Venofer®
- Where
- Austria
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Azad Pharma AG
Chronic Obstructive Pulmonary Disease
A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot)
Primary Objective: To evaluate the pharmacokinetics of Tiotropium Bromide Inhalation Powder (Strength:18 mcg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co.
- Trial name
- NCT06326671
- Testing
- Tiotropium Bromide Inhalation Powder, Spiriva HandiHaler
- Where
- China
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Chronic Pain
OTR Tablet 40 mg Fasted-state Bioequivalence Study
This is an open-label, single dose, randomised, cross-over study to confirm the bioequivalence (BE) of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fasted state in Chinese subjects with chronic pain
- Trial name
- NCT03398278
- Testing
- Oxycodone Tamper Resistant, OXYCONTIN®
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
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