NCT01874080

Brief Summary

The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

April 23, 2015

Status Verified

March 1, 2015

Enrollment Period

1 month

First QC Date

June 6, 2013

Last Update Submit

April 21, 2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (6)

  • Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)

    Cmax=Maximum observed plasma concentration CI=Confidence interval FDC=Fixed dosed combination XR=Extended release

    19 time points up to Day 3 of Periods 1 and 2

  • Point estimates and 90% CIs for the ratio of geometric means for AUC(0-T) for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)

    AUC(0-T)=Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration

    19 time points up to Day 3 of Periods 1 and 2

  • Point estimates and 90% CIs for the ratio of geometric means for AUC(INF) for Saxagliptin and Metformin in the 5/1000 mg FDC XR (Mt.Vernon/Humacao) and 5/1000 mg FDC XR (Mt. Vernon)

    AUC(INF)=Area under the plasma concentration-time curve from time zero extrapolated to infinity

    19 time points up to Day 3 of Periods 1 and 2

  • Point estimates and 90% CIs for the ratio of geometric means for Cmax for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon)

    19 time points up to Day 3 of Periods 1 and 2

  • Point estimates and 90% CIs for the ratio of geometric means for AUC(0-T) for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon)

    19 time points up to Day 3 of Periods 1 and 2

  • Point estimates and 90% CIs for the ratio of geometric means for AUC(INF) for Saxagliptin and Metformin in the 5/500 mg FDC XR (Mt. Vernon/Humacao) and 5/500 mg FDC XR (Mt. Vernon)

    19 time points up to Day 3 of Periods 1 and 2

Secondary Outcomes (6)

  • Time to maximum observed plasma concentration (Tmax) for Saxagliptin and Metformin and for 5-OH Saxagliptin (Treatments A, B, C, and D)

    19 time points up to Day 3 of Periods 1 and 2

  • Terminal half life (T-HALF) for Saxagliptin and Metformin and for 5-OH Saxagliptin (Treatments A, B, C, and D)

    19 time points up to Day 3 of Periods 1 and 2

  • Cmax for 5-OH Saxagliptin (Treatments A, B, C, and D)

    19 time points up to Day 3 of Periods 1 and 2

  • AUC(0-T) for 5-OH Saxagliptin (Treatments A, B, C, and D)

    19 time points up to Day 3 of Periods 1 and 2

  • AUC(INF) for 5-OH Saxagliptin (Treatments A, B, C, and D)

    19 time points up to Day 3 of Periods 1 and 2

  • +1 more secondary outcomes

Study Arms (4)

Arm A: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)

EXPERIMENTAL

Saxagliptin 5 mg /Metformin 1000 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day 1 of Periods 1 and 2

Drug: Saxagliptin/Metformin

Arm B: Saxagliptin/Metformin XR FDC (Mt. Vernon)

EXPERIMENTAL

Saxagliptin 5 mg/Metformin 1000 mg (Mt. Vernon) tablet by mouth once daily on Day 1 of Periods 1 and 2

Drug: Saxagliptin/Metformin

Arm C: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)

EXPERIMENTAL

Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day1 of Periods 1 and 2

Drug: Saxagliptin/Metformin

Arm D: Saxagliptin/Metformin XR FDC (Mt. Vernon)

EXPERIMENTAL

Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon) tablet by mouth once daily Day 1 of Periods 1 and 2

Drug: Saxagliptin/Metformin

Interventions

Saxagliptin/MetforminDRUG
Also known as: Kombiglyze XR
Arm A: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)Arm B: Saxagliptin/Metformin XR FDC (Mt. Vernon)Arm C: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao)Arm D: Saxagliptin/Metformin XR FDC (Mt. Vernon)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female subjects, 18-45 years of age
  • Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive
  • Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product

You may not qualify if:

  • Any significant acute or chronic medical illness
  • Estimated creatinine clearance of \<60 mL/min as calculated using the Modification of Diet in Renal Disease method Current or recent (within 3 months of study drug administration)
  • Gastrointestinal (GI) disease that could affect the absorption of study drug
  • Inability to tolerate oral medication
  • History of allergies or adverse reactions to DPP4 inhibitors or Metformin or related compounds
  • Current smoker or recent (within 6 months of study drug administration) history of regular tobacco use (positive cotinine test)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icon Development Solutions

San Antonio, Texas, 78209, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

saxagliptinMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

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

June 6, 2013

First Posted

June 10, 2013

Study Start

June 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 23, 2015

Record last verified: 2015-03

Locations

US(1)