ClinicalTrials.gov
ClinicalTrials.gov Menu

BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01305551
Recruitment Status : Withdrawn
First Posted : February 28, 2011
Last Update Posted : June 5, 2014
Sponsor:
Information provided by:
AstraZeneca

February 25, 2011
February 28, 2011
June 5, 2014
March 2011
March 2011   (Final data collection date for primary outcome measure)
  • Evidence of 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: 48 hours after dosing ]
  • Evidence of 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: 48 hours after dosing ]
  • Evidence of BE on single-dose pharmacokinetic parameters (AUC(0-T) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. [ Time Frame: 48 hours after dosing ]
    Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
  • Evidence of BE on single-dose pharmacokinetic parameters area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) derived from Saxagliptin, 5-Hydroxy Saxagliptin and Metformin plasma concentration versus time data. [ Time Frame: 48 hours after dosing ]
  • Evidence of 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: 48 hours after dosing ]
Same as current
Complete list of historical versions of study NCT01305551 on ClinicalTrials.gov Archive Site
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 days after dosing ]
  • Active metabolite of Saxagliptin, 5-Hydroxy Saxagliptin, from 5 mg Saxagliptin/500 mg Metformin XR FDC tablet & from 5 mg Onglyza administered together with 500 mg Glifage® XR in single-dose fed & fasted state pharmacokinetics in healthy subjects [ Time Frame: 3 days after dosing ]
    Amount of the active metabolite of Saxagliptin, 5-Hydroxy Saxagliptin (BMS-510849), from the 5 mg Saxagliptin/500 mg Metformin XR FDC tablet and from 5 mg Onglyza™ administered together with 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) in single-dose fed and fasted state pharmacokinetics in healthy subjects
Same as current
Not Provided
Not Provided
 
BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin Hydrochloride (HCl) XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin extended release (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.
Primary purpose: To demonstrate the bioequivalence of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin XR 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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Type 2 Diabetes
  • Drug: Saxagliptin
    Tablet, Oral, 5 mg, once on Day 1 only
    Other Name: Onglyza
  • Drug: Metformin XR
    Tablet, Oral, 500 mg, once on Day 1 only
    Other Name: Glifage XR
  • Drug: Saxagliptin/Metformin XR FDC
    Tablet, Oral, 5/500 mg, once on Day 1 only
    Other Name: Onglyza/Glucophage
  • Experimental: Treatment A-Saxagliptin+Metformin XR
    5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fasted state.
    Interventions:
    • Drug: Saxagliptin
    • Drug: Metformin XR
  • Experimental: Treatment B-Saxagliptin/Metformin XR FDC
    5mg Saxagliptin / 500 mg Metformin XR FDC tablet, once on Day 1 only, administered in the fasted state.
    Intervention: Drug: Saxagliptin/Metformin XR FDC
  • Experimental: Treatment C-Saxagliptin+Metformin XR
    5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fed state.
    Interventions:
    • Drug: Saxagliptin
    • Drug: Metformin XR
  • Experimental: Treatment D-Saxagliptin/Metformin XR FDC
    5mg Saxagliptin / 500 mg Metformin XR FDC tablet, once on Day 1 only, administered in the fed state.
    Intervention: Drug: Saxagliptin/Metformin XR FDC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
55
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy men and women
  • Women of childbearing potential (WOCBP) who are using acceptable method of contraception
  • Women who are not 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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01305551
CV181-146
No
Not Provided
Not Provided
Study Director, Bristol-Myers Squibb
AstraZeneca
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP