Bioequivalence Study for Acarbose / Metformin FDC

Bayer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type II

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01728740

15420

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 4 patient groups

Acarbose/Metformin FDC

Experimental group

Description:

Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Acarbose/Metformin FDC; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose/Metformin FDC (containing 50 mg Acarbose and 500 mg Metformin)

Treatment:

Drug: Acarbose/Metformin FDC (BAY81-9783)

Acarbose+Metformin

Active Comparator group

Description:

Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg

Treatment:

Drug: Metformin

Drug: Acarbose (Glucobay, BAYG5421)

Acarbose

Active Comparator group

Description:

Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose 50 mg

Treatment:

Drug: Acarbose (Glucobay, BAYG5421)

Metformin

Active Comparator group

Description:

Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Metformin 500 mg

Treatment:

Drug: Metformin