A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets
Overview[ - collapse ][ - ]
| Purpose | The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet. |
|---|---|
| Condition | Healthy Volunteers |
| Intervention | Drug: Dapagliflozin/Metformin Drug: Dapagliflozin Drug: Metformin Drug: Dapagliflozin/Metformin Drug: Dapagliflozin Drug: Metformin |
| Phase | Phase 1 |
| Sponsor | AstraZeneca |
| Responsible Party | AstraZeneca |
| ClinicalTrials.gov Identifier | NCT01055691 |
| First Received | January 25, 2010 |
| Last Updated | May 31, 2012 |
| Last verified | May 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 25, 2010 |
|---|---|
| Last Updated Date | May 31, 2012 |
| Start Date | January 2010 |
| Estimated Primary Completion Date | April 2010 |
| Current Primary Outcome Measures | bioequivalence will be demonstrated if the 90% confidence interval (CI) for the formulation effect is contained within the interval of 0.8000-1.2500 for AUC(0-t), AUCinf and Cmax with respect to both dapagliflozin and metformin. [Time Frame: Immediately prior to administration of the investigational product (IP). After intake of IP PK blood samples will be drawn every 15 minutes for the first hour, every 30 minutes for the second hour and every hour up to 72 h after intake of IP.] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | To examine the safety and tolerability of the combination of dapagliflozin and metformin. [Time Frame: Throughout study (for 4 days in each period and a follow-up visit ~6 days later)] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets |
|---|---|
| Official Title | A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Volunteers, in the Fed State |
| Brief Summary | The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs. the individual dapagliflozin tablet and individual metformin tablet. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science |
| Condition | Healthy Volunteers |
| Intervention | Drug: Dapagliflozin/Metformin Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose Drug: Dapagliflozin dapagliflozin tablet 2.5 mg Oral Single dose Drug: Metformin metformin IR tablet 850 mg Oral Single dose Other Names: GlucophageDrug: Dapagliflozin/Metformin Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose Drug: Dapagliflozin dapagliflozin tablet 5 mg Oral Single dose Drug: Metformin metformin IR tablet 1000 mg Oral Single dose Other Names: Glucophage |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 120 |
| Estimated Completion Date | April 2010 |
| Estimated Primary Completion Date | April 2010 |
| Eligibility Criteria | Inclusion Criteria: - Female healthy volunteers must be post-menopausal (cessation of menses >1year), be surgically sterile (documented) or hysterectomy or on abstinence - Have normal physical exam, vital signs Electrocardiogram (ECG) findings, and laboratory values Exclusion Criteria: - Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization - History of allergy to metformin - Previous participation in an AstraZeneca (AZ) or BristolMyers-Sqibb dapagliflozin study |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Germany |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01055691 |
|---|---|
| Other Study ID Numbers | D1691C00002 |
| Has Data Monitoring Committee | No |
| Information Provided By | AstraZeneca |
| Study Sponsor | AstraZeneca |
| Collaborators | Bristol-Myers Squibb |
| Investigators | Principal Investigator: Georg Golor, M.D. PAREXEL International GmbHStudy Director: Thomas Koernicke PAREXEL International GmbH |
| Verification Date | May 2012 |
Locations[ + expand ][ + ]
| Research Site | Berlin, Germany |
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