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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type II
• Intervention / Treatment: Drug: Acarbose/Metformin FDC (BAY81-9783); Drug: Acarbose (Glucobay, BAYG5421); Drug: Metformin

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acarbose/Metformin FDC; 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)	Drug: Acarbose/Metformin FDC (BAY81-9783); Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose
Active Comparator: Acarbose+Metformin; 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	Drug: Acarbose (Glucobay, BAYG5421); Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose; Drug: Metformin; Metformin 500mg, oral, single dose
Active Comparator: Acarbose; 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	Drug: Acarbose (Glucobay, BAYG5421); Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose
Active Comparator: Metformin; 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	Drug: Metformin; Metformin 500mg, oral, single dose

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 14, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Estimate): December 19, 2012
• Last Update Submitted That Met QC Criteria: December 18, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Metformin; Bioequivalence; Acarbose; FDC
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Metformin; Acarbose
• Other Study ID Numbers: 15420