5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00835497
First received: January 30, 2009
Last updated: September 9, 2009
Last verified: September 2009
  Purpose

This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA Pharmaceuticals USA with that of 5 mg/500 mg METAGLIP™ Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult subjects administered under fasting conditions.


Condition Intervention Phase
Healthy
Drug: 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets
Drug: 5 mg/500 mg METAGLIP™ Tablets
Phase 1

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 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax (Maximum Observed Concentration) - Glipizide in Plasma [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]- Glipizide [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]
  • AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]
  • Cmax (Maximum Observed Concentration) - Metformin in Plasma [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]
  • AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]- Metformin [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2004
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glipizide Metformin
Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period
Drug: 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets
1 x 5 mg/500 mg, single-dose fasting
Active Comparator: Metaglip®
Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
Drug: 5 mg/500 mg METAGLIP™ Tablets
1 x 5 mg/500 mg, single-dose fasting

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Screening Demographics: All subjects selected for this study will be healthy men and women 18-45 years of age, inclusive, at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30.
  • Screening Procedures: Each subject will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.

Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.

The screening clinical laboratory procedures will include:

  • Hematology: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;
  • Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;
  • HIV antibody, hepatitis B surface antigen, and hepatitis C antibody screens;
  • Urinalysis: by dipstick; full microscopic examination if dipstick positive; and
  • Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates, and phencyclidine.
  • Serum Pregnancy Screen

If female and:

  • of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), or abstinence; or
  • is postmenopausal for at least 1 year; or
  • is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

  • Subjects with a recent history of drug or alcohol addiction or abuse.
  • Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
  • Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
  • Subjects demonstrating a reactive hepatitis B surface antigen screen, a reactive hepatitis C antibody screen, or a reactive HIV antibody screen.
  • Subjects demonstrating a positive drug abuse screen when screened for this study.
  • Female subjects demonstrating a positive pregnancy screen.
  • Female subjects who are currently breastfeeding.
  • Subjects with a history of allergic response(s) to glipizide, metformin hydrochloride, or related drugs.
  • Subjects with a history of clinically significant allergies including drug allergies.
  • Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
  • Subjects who currently use or report using tobacco products within 90 days of Period I dose administration.
  • Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
  • Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
  • Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
  • Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.
  • Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
  • Subjects who report an intolerance of direct venipuncture.
  • Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835497

Locations
United States, Minnesota
PRACS Institute Ltd.
East Grand Forks, Minnesota, United States, 56721
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: James D. Carlson, Pharm.D. PRACS Institute, Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00835497     History of Changes
Other Study ID Numbers: R04-0476
Study First Received: January 30, 2009
Results First Received: July 2, 2009
Last Updated: September 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

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

ClinicalTrials.gov processed this record on April 14, 2014