Bioequivalence Study for Acarbose / Metformin FDC

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01728740

Enrollment

Registered

2012-11-20

Start date

2012-09-30

Completion date

2012-12-31

Last updated

2012-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type II

Keywords

Bioequivalence, Acarbose, Metformin, FDC

Brief summary

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

Interventions

DRUGAcarbose/Metformin FDC (BAY81-9783)

Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose

DRUGAcarbose (Glucobay, BAYG5421)

Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose

DRUGMetformin

Metformin 500mg, oral, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)	within 4 hours after sucrose load
Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)	within 4 hours after sucrose load
Cmax of metformin	within 24 hours after dosing
AUC(0-tn) of metformin	within 24 hours after dosing

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026