Drug Interaction With Metformin

Healthy Male and Female Subjects Clinical Trial

Official title:

Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546741
• Other study ID #: MB102-026
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2007
• Last updated: December 19, 2016
• Start date: November 2007
• Est. completion date: February 2008

Study information

• Verified date: December 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2

Exclusion Criteria:

• Unwilling to use acceptable method of birth control

• current or recent (within 1 month) smoker

• abnormal liver function tests

• presence of edema

• history of diabetes mellitus

• history of heart failure or renal insufficiency

• history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections

• history of Hepatitis C

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Male and Female Subjects

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, 20 mg, once daily single dose
• Metformin
Tablets, Oral, 1000 mg, once daily, single dose
• Dapagliflozin + Metformin
Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg

Locations

Country	Name	City	State
United States	Bristol-Myers Squibb Clinical Pharmacology Unit	Hamilton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment		measures taken daily throughout the study	No
Secondary	To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment		measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period)	Yes

External Links

•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
•   MB102026 _Redacted _CSR _synopsis