Bioequivalence Study for Acarbose / Metformin FDC

Diabetes Mellitus, Type II Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728740
• Other study ID #: 15420
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2012
• Last updated: December 18, 2012
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• Acarbose/Metformin FDC (BAY81-9783)
Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose
• Acarbose (Glucobay, BAYG5421)
Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose
• Metformin
Metformin 500mg, oral, single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Cmax of metformin		within 24 hours after dosing	No
Primary	AUC(0-tn) of metformin		within 24 hours after dosing	No

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