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Completed

NCT Number: NCT01554631

A 3-fold Crossover Bioequivalence Study Between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay Standard Tablet 100 mg

To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) 100 mg taken without or with water and the Glucobay standard tablet 100 mg taken with water.

Completed

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus 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

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subject
  • Age: 18 to 45 years (inclusive) at the first screening examination / visit
  • Ethnicity: White
  • Body mass index (BMI): above/equal 18 and below/equal 28 kg / m²

Exclusion criteria

  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
  • Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
  • Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
  • Known severe allergies, non-allergic drug reactions, or multiple drug allergies
  • Chronic intestinal disorders associated with distinct disturbances of digestion and absorption
  • States which may deteriorate as a result of increased gas formation in the intestine (e.g. Roemheld´s syndrome, major hernias, intestinal obstructions, intestinal ulcers, Crohn´s disease, ulcerative colitis, malabsorptions)
  • Fasting blood glucose level outside normal range
  • Impaired glucose tolerance in glucose tolerance test

Treatment and study plan

Acarbose (Glucobay ODT, BAYG5421)

Drug

Acarbose (Glucobay, BAYG5421)

Drug

Primary outcomes

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

    Time frame: within 4 hours after sucrose load

  2. Ratio of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0)

    Time frame: within 4 hours after sucrose load

Secondary outcomes

  1. Difference in postprandial maximum concentration (Cmax) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0)

    Time frame: within 4 hours after sucrose load

  2. Difference in postprandial area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0)

    Time frame: within 4 hours after sucrose load

  3. Safety parameters

    Time frame: Assessed in pre study treatment, study treatment, and follow-up visits

    Adverse events (AEs), clinical chemistry, hematology, urinalysis, physical examination, systolic and diastolic blood pressure, pulse rate, electrocardiogram (ECG)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Randomized, Non-blinded, 3-fold Crossover Study to Investigate the Bioequivalence Between Glucobay ODT 100 mg Taken Without and With Water and the Glucobay Standard Tablet 100 mg Following Single Oral Dosing in Healthy Male Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2012
Registry last updated
Jun 14, 2013

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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