Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00562250
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 11
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Dapagliflozin; Drug: Glimepiride; Drug: Dapagliflozin + Glimepiride	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Dapagliflozin; Tablets, Oral, 20 mg, once daily, single dose
Active Comparator: Arm 2	Drug: Glimepiride; Tablets, Oral, 4 mg, once daily, single dose
Active Comparator: Arm 3	Drug: Dapagliflozin + Glimepiride; Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose

Outcome Measures

Primary Outcome Measures

1. Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together [plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose]

Secondary Outcome Measures

1. Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride [for 72 hours after each administered dose]

2. Recorded adverse events [for 72 hours after each administered dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy subjects with BMI of 18-32 kg/m2

Exclusion Criteria:

• Abnormal physical or lab findings

• Allergies to any sulfonylurea or related compounds

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Vicente Lopez	Buenos Aires	Argentina	1602

Sponsors and Collaborators

• AstraZeneca
• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MB102-016 _CSR _synosis

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00562250
• Other Study ID Numbers: MB102-016
• First Posted: Nov 22, 2007
• Last Update Posted: Oct 17, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Dapagliflozin; Glimepiride

Study Results

No Results Posted as of Oct 17, 2016