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OpenTrials
Completed

NCT Number: NCT01055691

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female healthy volunteers must be post-menopausal (cessation of menses >1year), be surgically sterile (documented) or hysterectomy or on abstinence
  • Have normal physical exam, vital signs Electrocardiogram (ECG) findings, and laboratory values

Exclusion criteria

  • Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization
  • History of allergy to metformin
  • Previous participation in an AstraZeneca (AZ) or BristolMyers-Sqibb dapagliflozin study

Treatment and study plan

Dapagliflozin/Metformin

Drug

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

Dapagliflozin

Drug

dapagliflozin tablet 2.5 mg Oral Single dose

metformin

Drug

metformin IR tablet 850 mg Oral Single dose

Other names: Glucophage

Primary outcomes

  1. bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin.

    Time frame: Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP.

Secondary outcomes

  1. To examine the safety and tolerability of the combination of dapagliflozin and metformin.

    Time frame: Throughout study (for 4 days in each period and a follow-up visit ~6 days later)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Volunteers, in the Fed State

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 26, 2010
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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