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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388153
• Other study ID #: 15624
• Secondary ID: 2011-000904-17
• Status: Completed
• Phase: Phase 1
• First received: July 4, 2011
• Last updated: August 27, 2013
• Start date: June 2011
• Est. completion date: August 2011

Study information

• Verified date: August 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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)		within 4 hours after sucrose load	No
Secondary	Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)		within 4 hours after sucrose load	No
Secondary	Difference of postprandial AUC(0-4) of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)		within 4 hours after sucrose load	No
Secondary	Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)		within 4 hours after sucrose load	No

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