Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562250
• Other study ID #: MB102-016
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2007
• Last updated: October 14, 2016
• Start date: May 2008
• Est. completion date: August 2008

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, 20 mg, once daily, single dose
• Glimepiride
Tablets, Oral, 4 mg, once daily, single dose
• Dapagliflozin + Glimepiride
Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose

Locations

Country	Name	City	State
Argentina	Local Institution	Vicente Lopez	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Recorded adverse events		for 72 hours after each administered dose	Yes

External Links

•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   MB102-016 _CSR _synosis