- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01089192
Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fasting Conditions.
An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets (Test Formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Volunteers Under Fasting Conditions.
Objective:
To study Bioequivalence of Metformin Hydrochloride Extended Release 750 mg Tablets (Test formulation, Torrent Pharmaceuticals Ltd., India) Versus Glucophage XR® 750 mg Tablet (Reference formulation, Bristol-Myers Squibb company, USA) in Healthy volunteers under Fasting Conditions.
Study Design:
An Open-Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study
Study Overview
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Gujarat
-
Bhat, Gujarat, India, 382 428
- Torrent Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Volunteers must meet all of the following criteria in order to be included in the study:
- Sex: male.
- Age: 18 - 45 years.
- Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- Healthy and willing to participate in the study.
- Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
- Non-smokers or smoker who smokes less than 10 cigarettes a day.
Exclusion Criteria:
The volunteers will be excluded from the study based on the following criteria:
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically significant abnormal ECG or Chest X-ray.
- Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- Pulse rate less than 50/minute or more than 100/minute.
- Oral temperature less than 95°F or more than 98.6°F.
- Respiratory rate less than 12/minute or more than 20/minute
- Addiction to alcohol or history of any drug abuse within the past 2 years.
- Recent History of kidney or liver dysfunction.
- History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- Administration/ Intake of prescription or OTC medication for two weeks before the study.
- Patients suffering from any chronic illness such as arthritis, asthma etc.
- HIV, HCV, HBsAg positive volunteers.
- Opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, Cocaine positive volunteers based on urine test.
- Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
- Administration of any investigational products in the period 0 to 3 months before entry to the study.
- Intake of barbiturates or any enzyme-inducing drug in last three months.
- History of significant blood loss due to any reason, including blood donation in the past 12 weeks. The total blood loss in last 3 months including for this study will not exceed 350ml.
- Existence of any surgical or medical condition, which, in the judgement of the Chief Investigator and/or clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
- Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Study Plan
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Glucophage XR® of Bristol- Myers Squibb Company, USA)
|
|
Experimental: Torrent's Metformin tablets 750 mg
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PK-07-018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Not yet recruiting
-
Beijing Chao Yang HospitalNot yet recruitingType 2 Diabetes MellitusChina
-
Vinmec Research Institute of Stem Cell and Gene...CompletedType 2 Diabetes MellitusVietnam
-
Tehran University of Medical SciencesCompleted
-
Insulet CorporationCompletedType 2 Diabetes MellitusUnited States
-
Seoul National University Bundang HospitalAstellas Pharma Korea, Inc.CompletedType 2 Diabetes MellitusKorea, Republic of
Clinical Trials on Metformin
-
Anji PharmaSuspendedDiabetes Mellitus, Type 2Spain, United States, Canada, Hungary, Brazil, Czechia, Poland, Bulgaria
-
ShionogiCompleted
-
NuSirt BiopharmaCompletedType 2 Diabetes MellitusUnited States
-
Bristol-Myers SquibbCompletedType 2 Diabetes MellitusSouth Africa, United States, Canada, Puerto Rico, Hungary, Germany, Czechia, Poland, Romania, United Kingdom
-
Charles University, Czech RepublicCompleted
-
Hoffmann-La RocheCompletedDiabetes Mellitus Type 2United States, Mexico, Argentina
-
Hadassah Medical OrganizationWithdrawn
-
Woman'sPfizer; American Cancer Society, Inc.; Our Lady of the Lake Regional Medical...WithdrawnInsulin Resistance | Breast Cancer Stage | Racial BiasUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
University Hospital, Basel, SwitzerlandCompletedBecker's Muscular Dystrophy (BMD)Switzerland