Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

Official title:

Bioavailability Study of Two Prototype Fixed Dose Combination (FDC) Formulations of 10 mg Dapagliflozin and 1000 mg Metformin Extended Release (XR) Tablet Relative to Dapagliflozin 10 mg Tablet and Glucophage® XR 2 X 500 mg Tablets Coadministered to Healthy Subjects in a Fasted State

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002807
• Other study ID #: MB102-065
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2009
• Last updated: October 14, 2016
• Start date: November 2009
• Est. completion date: January 2010

Study information

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

Clinical Trial Summary

To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Men and women ages 18 to 45 inclusive

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

• Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2

Exclusion Criteria:

• WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product

• Any significant acute or chronic medical illness

• Current or recent (within 3 months) gastrointestinal disease

• Any major surgery within 4 weeks of study drug administration

• Glucosuria at screening

• Abnormal liver functions tests (ALT, AST or total bilirubin > 10% above ULN)

• Presence of edema on physical exam

• History of diabetes mellitus

• History of heart failure

• History of renal insufficiency

• History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months

• History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections

• Estimated creatinine clearance (ClCR) of < 80 mL/min using the Cockcroft Gault formula

• History of allergy or intolerance to metformin or other similar agents

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, 10 mg, Single Dose
• Metformin XR
Tablets, Oral, 1000 mg, Single Dose
• Glucophage
Tablets, Oral, 1000 mg, Single Dose

Locations

Country	Name	City	State
United States	Ppd Development, Lp	Austin	Texas

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	Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone		48 hours post-dose	No
Secondary	Safety and tolerability measures (adverse events, physical exams, vital signs, ECGs, and clinical laboratory assessments)		15 timepoints in 48 hours time interval	Yes

External Links

•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   MB102-065_redacted_CSR_synopsis