A 3-fold Crossover Bioequivalence Study Between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay Standard Tablet
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01388153
First received: July 4, 2011
Last updated: August 28, 2012
Last verified: August 2012
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Purpose
To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken without or with water and the Glucobay standard tablet taken with water
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Acarbose (Glucobay ODT, BAYG5421) Drug: Acarbose (Glucobay, BAYG5421) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
- 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) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
- Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
- Difference of postprandial AUC(0-4) of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
- Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | June 2011 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
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
|
| Experimental: Arm 2 |
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 with water
|
| Active Comparator: Arm 3 |
Drug: 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Head Clinical Pharmacology, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01388153 History of Changes |
| Other Study ID Numbers: | 15624, 2011-000904-17 |
| Study First Received: | July 4, 2011 |
| Last Updated: | August 28, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Bayer:
|
Bioequivalence, acarbose, ODT |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Acarbose |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013