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Bioequivalence Study for Acarbose / Metformin FDC

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type II

Intervention: Acarbose/Metformin FDC (BAY81-9783) (Drug); Acarbose (Glucobay, BAYG5421) (Drug); Metformin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).

Clinical Details

Official title: Randomized, Non-blinded Crossover Study to Establish the Bioequivalence Between Fixed Dose Combination (FDC) and Loose Combination of Acarbose and Metformin and to Investigate the Potential for a Drug-drug Interaction Following Single Oral Dosing in Healthy Adult Male Subjects

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)

Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)

Cmax of metformin

AUC(0-tn) of metformin

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)

- Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range

(4. 3-5. 6%, inclusive)

- Results of the 75 g oral glucose tolerance test (OGTT) during screening show:

- Blood glucose before OGTT <110 mg/dL.

- Blood glucose 1 hour after glucose loading <180 mg/dL

- Blood glucose 2 hours after glucose loading <140 mg/dL

Exclusion Criteria:

- A history of relevant diseases of internal organs (diabetes mellitus, Ileus,

Ileus-like symptoms, diseases that may significantly jeopardize body systems

- Febrile illness within 1 week before drug administration

- Family history of diabetes (within the second degree of relationship)

- Known drug hypersensitivity or idiosyncrasy

- Known severe allergies, non-allergic drug reactions, or multiple drug allergies

- Habitual medication including Chinese herbal drugs

- Intake of any drugs within 2 weeks of drug administration of period 1

- Regular daily consumption of more than 1 L of usual beer or the equivalent quantity

of approximately 40 g of alcohol in another form

- Donation of more than 150 mL of blood within 4 weeks before the screening examination

- Participation in another clinical trial within 4 weeks before the screening

examination

Locations and Contacts

Seoul 110-744, Korea, Republic of
Additional Information

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Starting date: September 2012
Last updated: December 18, 2012

Page last updated: August 23, 2015

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