Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00562250

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 I

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Drug Reactions

Drug Information available for: Glimepiride BMS 512148

U.S. FDA Resources

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

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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 February 09, 2012