Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects
1 other identifier
interventional
18
1 country
1
Brief Summary
To assess the effect of glimepiride on the PK of dapagliflozin and the effect of dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A) and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 type-2-diabetes-mellitus
Started Mar 2009
Shorter than P25 for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2009
CompletedFirst Posted
Study publicly available on registry
February 12, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedOctober 17, 2016
October 1, 2016
2 months
February 11, 2009
October 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
72 hours after dosing
Secondary Outcomes (1)
To assess the safety and tolerability in healthy subjects
15 time points up to 72 hours after dosing
Study Arms (5)
Dapagliflozin
ACTIVE COMPARATORGlimepiride
ACTIVE COMPARATORDapagliflozin + Glimepiride
ACTIVE COMPARATORSitagliptin
ACTIVE COMPARATORDapagliflozin + Sitagliptin
ACTIVE COMPARATORInterventions
Tablets, Oral, 20 mg, Single Dose
Tablets, Oral, 4 mg, Single Dose
Tablets, Oral, 100 mg, Single Dose
Eligibility Criteria
You may qualify if:
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive BMI = weight (kg)/\[height(m)\]2
You may not qualify if:
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
- Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
- History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
- History of allergy to SGLT@ inhibitors, DPP$ inhibitors or sulfonylurea or related compounds
- Prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of Day -1
- History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Ppd Development
Austin, Texas, 78744, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2009
First Posted
February 12, 2009
Study Start
March 1, 2009
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
October 17, 2016
Record last verified: 2016-10