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A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects

NCT02637037 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-03-13

Study results available
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Summary

This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions

Conditions

  • Bioequivalence
  • Fixed Dose Combination Tablets
  • Healthy Male and Female Subjects

Interventions

DRUG

dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)

single fixed-combination dose tablets

DRUG

dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)

single fixed-dose combination tablets

DRUG

dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)

single fixed-dose combination tablets

DRUG

dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)

single fixed-dose combination tablets

Sponsors & Collaborators

Principal Investigators

  • Ronald Goldwater, MDCM, M.Sc, CPI · PAREXEL Early Phase Clinical Unit Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-12-21
Primary Completion
2016-04-07
Completion
2016-04-07

Countries

  • United States

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 NCT02637037 on ClinicalTrials.gov