Drug Interaction With Metformin

NCT00546741 | Completed Phase 1

• 1 other identifier: MB102-026
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Male and Female Subjects

Keywords

Diabetes,NOS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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)

Study Arms (3)

1

EXPERIMENTAL

Drug: Dapagliflozin

2

ACTIVE COMPARATOR

Drug: Metformin

3

ACTIVE COMPARATOR

Drug: Dapagliflozin + Metformin

Interventions

Dapagliflozin DRUG

Tablets, Oral, 20 mg, once daily single dose

1

Metformin DRUG

Tablets, Oral, 1000 mg, once daily, single dose

2

Dapagliflozin + Metformin DRUG

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

3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Bristol-Myers Squibb Clinical Pharmacology Unit

Hamilton, New Jersey, 08690, United States

Location

Related Links

• MB102026 \_Redacted \_CSR \_synopsis

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

dapagliflozin; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 19, 2007
• Study Start: November 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: December 20, 2016

Record last verified: 2016-12

Locations

US (1)