A 3-fold Crossover Bioequivalence Study Between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay Standard Tablet 100 mg - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Acarbose (Glucobay ODT, BAYG5421) Drug: Acarbose (Glucobay, BAYG5421)	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-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 100 mg Taken Without and With Water and the Glucobay Standard Tablet 100 mg Following Single Oral Dosing in Healthy Male Subjects

Resource links provided by NLM:

Drug Information available for: Acarbose

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Ratio of postprandial maximum concentration (Cmax) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
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) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Difference in postprandial maximum concentration (Cmax) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
Difference in postprandial area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0) [ Time Frame: within 4 hours after sucrose load ] [ Designated as safety issue: No ]
Safety parameters [ Time Frame: Assessed in pre study treatment, study treatment, and follow-up visits ] [ Designated as safety issue: Yes ]
Adverse events (AEs), clinical chemistry, hematology, urinalysis, physical examination, systolic and diastolic blood pressure, pulse rate, electrocardiogram (ECG)


Enrollment:	34
Study Start Date:	March 2012
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT 100 mg; Day 1: oral sucrose load plus Glucobay ODT 100 mg taken without water	Drug: Acarbose (Glucobay ODT, BAYG5421)
Experimental: Arm 2 Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT 100 mg; Day 1: oral sucrose load plus Glucobay ODT 100 mg taken with water	Drug: Acarbose (Glucobay ODT, BAYG5421)
Active Comparator: Arm 3 Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet 100 mg; Day 1: oral sucrose load plus Glucobay standard tablet 100 mg taken with water	Drug: Acarbose (Glucobay, BAYG5421)

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554631

Locations


Germany

Mönchengladbach, Nordrhein-Westfalen, Germany, 41061

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site


Responsible Party:	Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT01554631 History of Changes
Other Study ID Numbers:	16025 2012-000245-12
Study First Received:	March 7, 2012
Last Updated:	June 13, 2013
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	Glycoside Hydrolase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016