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

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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Acarbose (Glucobay ODT, BAYG5421)
* Drug: Acarbose (Glucobay ODT, BAYG5421)
* Drug: Acarbose (Glucobay, BAYG5421)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Acarbose (Glucobay ODT, BAYG5421)<br>* 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<br>|
| Experimental: Arm 2<br> | Drug: Acarbose (Glucobay ODT, BAYG5421)<br>* 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<br>|
| Active Comparator: Arm 3<br> | Drug: Acarbose (Glucobay, BAYG5421)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) |  | within 4 hours after sucrose load | 
| 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 | 
| Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) |  | within 4 hours after sucrose load | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, acarbose, ODT