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Bioequivalence Study of Metformin Hydrochloride 1000mg Tablets Under Fasting Conditions

NCT ID: NCT00778427

Last Updated: 2008-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-04-30

Brief Summary

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The objective of this study was to evaluate the relative bioavailability of the test formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb Company) under fasted conditions in healthy, male and female adult subjects.

Detailed Description

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This randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 1000 mg metformin hydrochloride tablets under fasting conditions. The study was conducted with 32 (30 completing) healthy adults in accordance with Protocol No. 10640302 (Revision 0). In each study period, a single dose (1 x 1000 mg tablet) was administered to all subjects following an overnight fast of at least 10 hours. The test formulation was Ohm Laboratories, Inc's (A Group of Ranbaxy Pharmaceuticals Inc.) Metformin Hydrochloride 1000 mg Tablets and the reference formulation was GLUCOPHAGE® (metformin hydrochloride) 1000 mg Tablets (Bristol-Myers Squibb Company). The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.

Blood samples were collected pre-dose and at intervals over 24 hours after each dose. The plasma samples for all subjects completing both periods of the study were sent to Helen Fassoulas, Director of Operations, Warnex Bioanalytical Services Inc., 3885 boul Industriel, Laval, Quebec, H7L4S3 Canada, Telephone: 450-663-6724, Fax: 450-975-8111 for determination of metformin concentrations.

Statistical analysis was performed by Braulio Suarez, M.D., Novum Pharmaceutical Research Services, Wilcrest Green Office Park, 3320 Walnut Bend Lane, Houston, Texas 77042-4712, USA, Telephone: 832-251-8100, Fax: 832-251-7133.

A total of 32 healthy adult subjects (30 completing).

Conditions

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Healthy

Keywords

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Bioequivalence metformin hydrochloride 1000 mg tablets fasting conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

metformin hydrochloride 1000 mg tablets of Ranbaxy

Group Type EXPERIMENTAL

metformin hydrochloride 1000 mg tablets

Intervention Type DRUG

2

GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets

Group Type ACTIVE_COMPARATOR

metformin hydrochloride 1000 mg tablets

Intervention Type DRUG

Interventions

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metformin hydrochloride 1000 mg tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males and females, 18 to 60 years of age (inclusive).
2. A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum Standard Operating Procedures.
3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
4. Signed and dated informed consent form, which meets all criteria of current FDA regulations.
5. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study.

Exclusion Criteria

1. If female, pregnant, lactating or likely to become pregnant during the study.
2. History or allergy or sensitivity to metformin, other hyperglycemic agents, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
3. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
4. Presence of gastrointestinal disease or history of malabsorption within the last year.
5. History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
6. Presence of a medical condition requiring regular treatment with prescription drugs.
7. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
8. Receipt of any drug as part of a research study within 30 days prior to dosing.
9. Drug or alcohol addiction requiring treatment in the past 12 months.
10. Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
11. Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
12. Positive test results for drug of abuse at screening.
13. Positive serum pregnancy test.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ranbaxy Laboratories Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Ranbaxy research labs

Locations

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NovumPharmaceutical Research Services

Las Vegas, Nevada, United States

Site Status

Countries

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United States

Related Links

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http://clinicalstudies.ranbaxy.com

Related Info

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Related Info

http://www.fda.gov/opacom/7alerts.html

Related Info

Other Identifiers

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10640302

Identifier Type: -

Identifier Source: org_study_id