Who is sponsoring NCT01388153?

NCT01388153 is sponsored by Bayer.

What condition does NCT01388153 study?

NCT01388153 studies Diabetes Mellitus, Type 2.

What drugs are being tested in NCT01388153?

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

What is the status of NCT01388153?

NCT01388153 is currently COMPLETED.

Last reviewed 2013-08-27 · How we verify

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

NCT01388153 Phase 1 COMPLETED

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

Details

Lead sponsor	Bayer
Phase	Phase 1
Status	COMPLETED
Enrolment	33
Start date	2011-06
Completion	2011-08

Conditions

Diabetes Mellitus, Type 2

Interventions

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

Primary outcomes

Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2) — within 4 hours after sucrose load
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) — within 4 hours after sucrose load

Countries

Germany