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Bioequivalence Study for Acarbose / Metformin FDC

NCT01728740 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-12-19

No results posted yet for this study

Summary

To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).

Conditions

  • Diabetes Mellitus, Type II

Interventions

DRUG

Acarbose/Metformin FDC (BAY81-9783)

Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose

DRUG

Acarbose (Glucobay, BAYG5421)

Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose

DRUG

Metformin

Metformin 500mg, oral, single dose

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01728740 on ClinicalTrials.gov