Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00562250
First received: November 21, 2007
Last updated: November 4, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: Dapagliflozin
Drug: Glimepiride
Drug: Dapagliflozin + Glimepiride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together [ Time Frame: plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride [ Time Frame: for 72 hours after each administered dose ] [ Designated as safety issue: No ]
  • Recorded adverse events [ Time Frame: for 72 hours after each administered dose ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: May 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562250

Locations
Argentina
Local Institution
Vicente Lopez, Buenos Aires, Argentina, 1602
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00562250     History of Changes
Other Study ID Numbers: MB102-016
Study First Received: November 21, 2007
Last Updated: November 4, 2008
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014