Who is sponsoring NCT01554631?

NCT01554631 is sponsored by Bayer.

What condition does NCT01554631 study?

NCT01554631 studies Diabetes Mellitus, Type 2.

What drugs are being tested in NCT01554631?

Interventions: Acarbose (Glucobay ODT, BAYG5421), Acarbose (Glucobay, BAYG5421).

What is the status of NCT01554631?

NCT01554631 is currently COMPLETED.

Last reviewed 2013-06-13 · How we verify

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

NCT01554631 Phase 1 COMPLETED

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.

Details

Lead sponsor	Bayer
Phase	Phase 1
Status	COMPLETED
Enrolment	34
Start date	2012-03
Completion	2012-05

Conditions

Diabetes Mellitus, Type 2

Interventions

Acarbose (Glucobay ODT, BAYG5421)
Acarbose (Glucobay, BAYG5421)

Primary outcomes

Ratio of postprandial maximum concentration (Cmax) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0) — within 4 hours after sucrose load
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) — within 4 hours after sucrose load

Countries

Germany