Bioequivalence (BE) Study of Fixed Dose Combinations (FDC) of Saxagliptin/Metformin - Brazil
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01365091
First received: May 16, 2011
Last updated: December 8, 2011
Last verified: December 2011
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Purpose
To demonstrate the bioequivalence of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin XR fixed dose combination (FDC) tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.
To demonstrate the bioequivalence of Saxagliptin and Metformin from a 5 mg Saxagliptin/1000 mg Metformin XR FDC tablet relative to 5 mg Onglyza™ and 1000 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together to healthy subjects both in the fasted and fed states.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Saxagliptin/Metformin FDC Drug: Onglyza Drug: Glifage® XR |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Bioequivalence Study of Fixed Dose Combinations of Saxagliptin/Metformin Extended Release (XR) Relative to Co-administration of the Individual Components in Healthy Subjects in the Fasted and Fed States |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Evidence of bioequivalence (BE) on single-dose pharmacokinetic parameters maximum observed concentration (Cmax) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. [ Time Frame: In the 48 hours after dosing ] [ Designated as safety issue: No ]
- Evidence of bioequivalence (BE) on single-dose pharmacokinetic parameters time of maximum observed concentration (Tmax) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. [ Time Frame: In the 48 hours after dosing ] [ Designated as safety issue: No ]
- Evidence of bioequivalence (BE) on single-dose pharmacokinetic parameters AUC(0-T) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. [ Time Frame: In the 48 hours after dosing ] [ Designated as safety issue: No ]area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
- Evidence of bioequivalence (BE) on single-dose pharmacokinetic parameters AUC(INF) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. [ Time Frame: In the 48 hours after dosing ] [ Designated as safety issue: No ]area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
- Evidence of bioequivalence (BE) on single-dose pharmacokinetic parameters half-life (T-HALF) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. [ Time Frame: In the 48 hours after dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants with adverse events. [ Time Frame: Adverse events collected from Day 1 of Period 1 through study discharge (study duration: approximately 46 days) ] [ Designated as safety issue: Yes ]Adverse events tabulated by system organ class, preferred term and formulation
- Levels of Active metabolite of Saxagliptin, 5-Hydroxy Saxagliptin (BMS-510849). [ Time Frame: In the 48 hours after dosing, respectively ] [ Designated as safety issue: No ]
| Enrollment: | 112 |
| Study Start Date: | June 2011 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A1: A-Saxagliptin/Metformin FDC, B-Onglyza & Glifage (Fasted) |
Drug: Saxagliptin/Metformin FDC
Tablet, Oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day
Other Name: Onglyza/Glucophage XR
Drug: Onglyza
Tablet, Oral, 5 mg, once on Day 1 only, 1 day
Other Name: Onglyza
Drug: Glifage® XR
Tablet, Oral, 500 mg, once on Day 1 only, 1 day
Other Name: Glifage XR
|
| Experimental: A2: C-Saxagliptin/Metformin FDC, D-Onglyza & Glifage (Fed) |
Drug: Saxagliptin/Metformin FDC
Tablet, Oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day
Other Name: Onglyza/Glucophage XR
Drug: Onglyza
Tablet, Oral, 5 mg, once on Day 1 only, 1 day
Other Name: Onglyza
Drug: Glifage® XR
Tablet, Oral, 500 mg, once on Day 1 only, 1 day
Other Name: Glifage XR
|
| Experimental: A3: E-Saxagliptin/Metformin FDC, F-Onglyza & Glifage (Fasted) |
Drug: Onglyza
Tablet, Oral, 5 mg, once on Day 1 only, 1 day
Other Name: Onglyza
Drug: Saxagliptin/Metformin FDC
Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day
Other Name: Onglyza/Glucophage XR
Drug: Glifage® XR
Tablet, Oral, 1000 mg, once on Day 1 only, 1 day
Other Name: Glifage XR
|
| Experimental: A4: G-Saxagliptin/Metformin FDC, H-Onglyza & Glifage (Fed) |
Drug: Onglyza
Tablet, Oral, 5 mg, once on Day 1 only, 1 day
Other Name: Onglyza
Drug: Saxagliptin/Metformin FDC
Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day
Other Name: Onglyza/Glucophage XR
Drug: Glifage® XR
Tablet, Oral, 1000 mg, once on Day 1 only, 1 day
Other Name: Glifage XR
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy men and women
- women of childbearing potential (WOCBP) who are using acceptable method of contraception
- Women who are not pregnant or nursing
Exclusion Criteria:
- History of Gastrointestinal (GI) disease
- Any GI surgery that could impact study drug absorption
- History of allergy to drug class or related compounds
- History of allergy to Metformin or other similar acting agents
- History of any significant drug allergy
- Estimated creatinine clearance (ClCr) < 80 mL/min using Cockcroft-Gault formula
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01365091 History of Changes |
| Other Study ID Numbers: | CV181-162 |
| Study First Received: | May 16, 2011 |
| Last Updated: | December 8, 2011 |
| Health Authority: | Brazil: Ethics Committee Brazil: National Health Surveillance Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Saxagliptin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013