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A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets

NCT01055691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-06-01

No results posted yet for this study

Summary

The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Dapagliflozin/Metformin

Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose

DRUG

Dapagliflozin

dapagliflozin tablet 2.5 mg Oral Single dose

DRUG

Metformin

metformin IR tablet 850 mg Oral Single dose

DRUG

Dapagliflozin/Metformin

Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose

DRUG

Dapagliflozin

dapagliflozin tablet 5 mg Oral Single dose

DRUG

Metformin

metformin IR tablet 1000 mg Oral Single dose

Sponsors & Collaborators

Principal Investigators

  • Georg Golor, M.D. · Parexel

  • Thomas Koernicke · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Germany

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 NCT01055691 on ClinicalTrials.gov