Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

NCT ID: NCT00562250

Last Updated: 2016-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 20 mg, once daily, single dose

Arm 2

Group Type ACTIVE_COMPARATOR

Glimepiride

Intervention Type DRUG

Tablets, Oral, 4 mg, once daily, single dose

Arm 3

Group Type ACTIVE_COMPARATOR

Dapagliflozin + Glimepiride

Intervention Type DRUG

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

Interventions

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Dapagliflozin

Tablets, Oral, 20 mg, once daily, single dose

Intervention Type DRUG

Glimepiride

Tablets, Oral, 4 mg, once daily, single dose

Intervention Type DRUG

Dapagliflozin + Glimepiride

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Vicente López, Buenos Aires, Argentina

Site Status

Countries

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Argentina

Related Links

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Other Identifiers

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MB102-016

Identifier Type: -

Identifier Source: org_study_id

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