Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fasting Conditions.

Overview[ - collapse ][ - ]

Purpose 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
ConditionType 2 Diabetes
InterventionDrug: Metformin
PhasePhase 1
SponsorTorrent Pharmaceuticals Limited
Responsible PartyTorrent Pharmaceuticals Limited
ClinicalTrials.gov IdentifierNCT01089192
First ReceivedMarch 16, 2010
Last UpdatedOctober 13, 2010
Last verifiedMarch 2010

Tracking Information[ + expand ][ + ]

First Received DateMarch 16, 2010
Last Updated DateOctober 13, 2010
Start DateNot Provided
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresNot Provided
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleBioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fasting Conditions.
Official TitleAn 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.
Brief Summary
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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignN/A
ConditionType 2 Diabetes
InterventionDrug: Metformin
Study Arm (s)
  • Experimental: Torrent's Metformin tablets 750 mg
  • Active Comparator: Glucophage XR® of Bristol- Myers Squibb Company, USA)

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated EnrollmentNot Provided
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot Provided
Eligibility Criteria
Inclusion Criteria:

- Volunteers must meet all of the following criteria in order to be included in the
study:

1. Sex: male.

2. Age: 18 - 45 years.

3. Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.

4. Healthy and willing to participate in the study.

5. Volunteer willing to adhere to the protocol requirements and to provide written
informed consent.

6. 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:

1. Clinically relevant abnormalities in the results of the laboratory screening
evaluation.

2. Clinically significant abnormal ECG or Chest X-ray.

3. 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.

4. Pulse rate less than 50/minute or more than 100/minute.

5. Oral temperature less than 95°F or more than 98.6°F.

6. Respiratory rate less than 12/minute or more than 20/minute

7. Addiction to alcohol or history of any drug abuse within the past 2 years.

8. Recent History of kidney or liver dysfunction.

9. History of allergy to the test drug or any drug chemically similar to the drug
under investigation.

10. Administration/ Intake of prescription or OTC medication for two weeks before
the study.

11. Patients suffering from any chronic illness such as arthritis, asthma etc.

12. HIV, HCV, HBsAg positive volunteers.

13. Opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine,
Cocaine positive volunteers based on urine test.

14. Volunteers suffering from any psychiatric (acute or chronic) illness requiring
medications.

15. Administration of any investigational products in the period 0 to 3 months
before entry to the study.

16. Intake of barbiturates or any enzyme-inducing drug in last three months.

17. 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.

18. 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.

19. Inability to communicate or co-operate due to language problem, poor mental
development or impaired cerebral function.
GenderMale
Ages18 Years
Accepts Healthy VolunteersNot Provided
ContactsNot Provided
Location CountriesIndia

Administrative Information[ + expand ][ + ]

NCT Number NCT01089192
Other Study ID NumbersPK-07-018
Has Data Monitoring CommitteeNot Provided
Information Provided ByTorrent Pharmaceuticals Limited
Study SponsorTorrent Pharmaceuticals Limited
CollaboratorsNot Provided
Investigators Not Provided
Verification DateMarch 2010

Locations[ + expand ][ + ]

Torrent Research Centre
Bhat, Gujarat, India, 382 428