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Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin Produc

NCT01441869 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-02-08

No results posted yet for this study

Summary

Study in healthy subjects to measure amount of drug in blood after dosing with different saxagliptin / metformin products.

Conditions

  • Bioequivalence, Log-transformed AUCss and Cmax,ss Values for Saxagliptin and Metformin

Interventions

DRUG

Onglyza (saxagliptin)

Oral tablets, 5 mg , single dose

DRUG

Diabex

Extended release oral tablets, 1000 mg, single dose

DRUG

5-mg saxagliptin/1000 mg metformin

Extended release fixed dose combination tablet, single dose

DRUG

Diabex

Extended release oral tablets, 500 mg, single dose

DRUG

5-mg saxagliptin/500 mg metformin

Extended release fixed dose combination tablet, single dose

Sponsors & Collaborators

Principal Investigators

  • Miriana Kujacic, MD · AstraZeneca Mölndal, Sweden

  • Phil Leese, MD · Quintiles, Inc. Overland Park US

  • Peter Öhman, MD · Astrazeneca, Wilmington, US

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
2011-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

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 NCT01441869 on ClinicalTrials.gov