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Completed

NCT Number: NCT01728740

Bioequivalence Study for Acarbose / Metformin FDC

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

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Key information

Conditions

Diabetes Mellitus, Type II Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acarbose/Metformin FDC (BAY81-9783)

Drug

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

Acarbose (Glucobay, BAYG5421)

Drug

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

metformin

Drug

Metformin 500mg, oral, single dose

Primary outcomes

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

    Time frame: within 4 hours after sucrose load

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

    Time frame: within 4 hours after sucrose load

  3. Cmax of metformin

    Time frame: within 24 hours after dosing

  4. AUC(0-tn) of metformin

    Time frame: within 24 hours after dosing

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 20, 2012
Registry last updated
Dec 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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