Study Completed

Diabetes Mellitus, Type 2

Bayer Identifier:

16025

ClinicalTrials.gov Identifier:

NCT01554631

EudraCT Number:

2012-000245-12

EU CT Number:

Not Available

A 3-fold crossover bioequivalence study between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay standard tablet 100 mg

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years

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

Trial summary

Enrollment Goal

Trial Dates

March 2012 - May 2012

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

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
Safety Issue:
No
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
Safety Issue:
No

Secondary Outcome

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
Safety Issue:
No
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
Safety Issue:
No
Safety parameters
Adverse events (AEs), clinical chemistry, hematology, urinalysis, physical examination, systolic and diastolic blood pressure, pulse rate, electrocardiogram (ECG)
Time Frame:
Assessed in pre study treatment, study treatment, and follow-up visits
Safety Issue:
Yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Non-randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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