A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Non-fasting Conditions

NCT00864734 | Completed Phase 1

• 1 other identifier: R02-995
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co. with that of 5 mg/500 mg CLUCOVANCE® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 5 mg/500 mg tablet) in healthy adult volunteers under non-fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Metformin; Glyburide; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  36 hours

Study Arms (2)

A

EXPERIMENTAL

Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg, single dose

Drug: Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg

B

ACTIVE COMPARATOR

CLUCOVANCE® 5 mg/500 mg Tablets, single dose

Drug: CLUCOVANCE® 5 mg/500 mg Tablets, single dose

Interventions

Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg DRUG

A: Experimental Subjects received Alpharma formulated products under non-fasting conditions

Also known as: Glyburide, Metformin

A

CLUCOVANCE® 5 mg/500 mg Tablets, single dose DRUG

B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under non-fasting conditions

Also known as: Glyburide, Metformin

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening Demographics: All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults -1983 Metropolitan Height and Weight Table.
• Screening Procedures: Each volunteer 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 and hepatitis B surface antigen screens;
• URINALYSIS: by dipstick, microscopic examination if dipstick positive; and
• URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.
• SERUM PREGNANCY SCREEN (female volunteers only)
• If female and:
• of childbearing potential, is practicing an acceptable barrier method of birth control for the duration of the study as judged by the investigator(s), such as condoms, sponge, foams, jellies, diaphragm; intrauterine device (IUD), or abstinence; or
• is postmenopausal for at least 1 year; or
• is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

You may not qualify if:

• Volunteers with a recent history of drug or alcohol addiction or abuse.
• Volunteers 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 medical investigator).
• Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
• Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
• Volunteers demonstrating a positive drug abuse screen when screened for this study.
• Female volunteers demonstrating a positive pregnancy screen.
• Female volunteers who are currently breastfeeding.
• Volunteers with a history of allergic response(s) to glyburide, metformin or related drugs.
• Volunteers with a history of clinically significant allergies including drug allergies.
• Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the medical investigator).
• Volunteers who currently use tobacco products.
• Volunteers who have taken any drug known to induce or inhibit hepatic• drug metabolism in the 28 days prior to Period I dosing.
• Volunteers 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.
• Volunteers 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.
• Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58102, United States

Location

MeSH Terms

Interventions

Glyburide; Metformin

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Biguanides; Guanidines; Amidines

Study Officials

• James D. Carlson,, Pharm. D.

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: November 1, 2002
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2002
• Last Updated: August 17, 2010

Record last verified: 2010-08

Locations

US (1)