Bioequivalence Study of Metformin HCl 750 mg XR Tablets Under Non Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00778141
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

The objective of this study is to compare the relative bioavailability of metformin HC1 750 mg extended-release tablets (Ranbaxy) with that of Glucophage® XR 750 mg tablets (Bristol Myers Squibb) in healthy, adult, subjects under non-fasting conditions.


Condition Intervention
Healthy
Drug: metformin HC1 750 mg extended-release tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of Metformin HCl 750 mg XR Tablets Under Non-Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: April 2004
Study Completion Date: June 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
metformin HC1 750 mg extended-release tablets
Drug: metformin HC1 750 mg extended-release tablets
Active Comparator: 2
Glucophage® XR 750 mg tablets
Drug: metformin HC1 750 mg extended-release tablets

Detailed Description:
  1. Design: Single dose, randomized, two-period, two-treatment, two- sequence crossover study under non-fasting conditions comparing equal doses of the test and reference products.
  2. Interval between dosing periods: At least one week
  3. Period of confinement: From at least 10.5 hours before dosing until after the 36 hour blood collection each period. Subjects will return to the clinic for subsequent blood collations.

A total of thirty six (36) subjects were enrolled in this study; 33 completed the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All subjects selected for this study will be at least 18 years of age.
  2. Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.
  3. Each female subject will be given a serum pregnancy test as part of the pre-study screening process. At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
  4. Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.
  5. Clinical laboratory measurements will include the hematology, clinical chemistry, urine analysis, HIV screening, Hepatitis B & C, drugs of abuse scan

Exclusion Criteria:

  1. Subjects with a significant recent history of chronic alcohol consumption or drug addiction (past two years), or serious gastrointestinal, renal, hepatic or cardio- vascular disease, tuberculosis, epilepsy, asthma (past five years), diabetes, psychosis or glaucoma will not be eligible for this study.
  2. Subjects whose clinical laboratory test values are outside the reference range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  3. Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study
  4. All subjects will have urine staples assayed for the presence of drugs of abuse as per of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
  5. Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
  6. Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate
  7. Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom) of contraception during the course of the study (first dosing until last blood collation) or they will not be allowed to participate. Female subjects who have used hormones or contraceptives within 14 days of dosing or implanted or injected hormone contraceptives within 180 days of dosing will not be allowed to participate.
  8. All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778141

Locations
United States, Missouri
Gateway medical research
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs
ClinicalTrials.gov Identifier: NCT00778141     History of Changes
Other Study ID Numbers: B045503
Study First Received: October 22, 2008
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
Bioequivalecne metformin HC1 750 mg extended-release tablets

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014