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Bioequivalence Study for Acarbose/Metformin FDC

NCT04065581 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-04-13

No results posted yet for this study

Summary

The purpose of this study is to establish the bioequivalence (i.e. similar pharmacokinetics and pharmacodynamics characteristics) between acarbose/metformin FDC (50 mg/500 mg) and loose combination of acarbose (50 mg) and metformin (500 mg)

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Acarbose/Metformin FDC(BAY81-9783)

Single dose: 50 mg acarbose/500 mg metformin tablet, oral

DRUG

Glucobay

Single dose: 50 mg tablet, oral

DRUG

Glucophage

Single dose: 500 mg tablet, oral

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2019-11-25
Completion
2020-03-06

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04065581 on ClinicalTrials.gov