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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01388153
First received: July 4, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Acarbose (Glucobay ODT, BAYG5421)
Drug: Acarbose (Glucobay, BAYG5421)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, Non-blinded, 3-fold Crossover Study to Investigate the Bioequivalence Between Glucobay ODT Taken Without and With Water and the Glucobay Standard Tablet Following Single Oral Dosing in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
  • Difference of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to reach maximum drug concentration in plasma after single dose (tmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
  • Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
  • Difference of postprandial AUC(0-4) of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
  • Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: June 2011
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Acarbose (Glucobay ODT, BAYG5421)
Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken without water
Experimental: Arm 2 Drug: Acarbose (Glucobay ODT, BAYG5421)
Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken with water
Active Comparator: Arm 3 Drug: Acarbose (Glucobay, BAYG5421)
Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet; Day 2: oral sucrose load plus Glucobay standard tablet taken with water

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The informed consent must be signed before any study specific tests or procedures are done
  • 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
  • Confirmation of the subject's health insurance coverage prior to the first screening examination / visit
  • Ability to understand and follow study-related instructions

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388153

Locations
Germany
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01388153     History of Changes
Other Study ID Numbers: 15624, 2011-000904-17
Study First Received: July 4, 2011
Last Updated: August 27, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Bioequivalence, acarbose, ODT

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014