Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00562250
First received: November 21, 2007
Last updated: November 4, 2008
Last verified: November 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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 May 19, 2013