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:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Official Title:	Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

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
Arm 1: Experimental	Drug: Dapagliflozin Tablets, Oral, 20 mg, once daily, single dose
Arm 2: Active Comparator	Drug: Glimepiride Tablets, Oral, 4 mg, once daily, single dose
Arm 3: Active Comparator	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, Buenos Aires
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:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	MB102-016
Study First Received:	November 21, 2007
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00562250 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010