Study Completed

Diabetes Mellitus, Type 2

Bayer Identifier:

15624

ClinicalTrials.gov Identifier:

NCT01388153

EudraCT Number:

2011-000904-17

EU CT Number:

Not Available

A 3-fold crossover bioequivalence study between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay standard tablet

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 45 Years

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

Trial summary

Enrollment Goal

Trial Dates

June 2011 - August 2011

Phase

Phase 1

Could I Receive a placebo

Products

Glucobay ODT (Acarbose, BAYG5421)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	CRS Clinical-Research-Services Mönchengladbach GmbH	Mönchengladbach, 41061, Germany

Primary Outcome

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
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
Safety Issue:
No

Secondary Outcome

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
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
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
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
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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