Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00897390
• Date of registration: 08/05/2009
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
• Scientific title: Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 1000 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 1000 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State
• Date of first enrolment: June 2009
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00897390
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women ages 19 to 45 inclusive

- Healthy subjects as determined by no clinically significant deviation from normal in
medical history, physical examination, electrocardiograms (ECGs), and clinical
laboratory determinations

- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2

Exclusion Criteria:

- Women of child-bearing potential (WOCBP) who are unwilling or unable to use acceptable
barrier methods (condoms and spermicides) to avoid pregnancy for the entire study
period and for up to 8 weeks after the last dose of investigational product

- Any significant acute or chronic medical illness

- Current or recent (within 3 months) gastrointestinal disease

- Any major surgery within 4 weeks of study drug administration

- History of allergy to Dipeptidyl peptidase 4 (DPP4) inhibitor or related compounds

- History of allergy or intolerance to metformin or other similar acting agents

- Prior exposure to saxagliptin

- Prior exposure to metformin within 3 months of study drug administration

- Estimated creatinine clearance (Clcr) of < 80ml/min using the Cockcroft Gault formula



Age minimum: 19 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Metformin IR (glucophage)

Drug: Saxagliptin + Metformin IR (FDC)

Drug: Saxagliptin

Primary Outcome(s)

Metformin PK Parameter AUC(0-T) [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Saxagliptin PK Parameter Plasma Terminal Half-life (T-HALF) [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Metformin PK Parameter AUC(INF) [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Metformin PK Parameter Cmax [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Saxagliptin PK Parameter Time of Maximum Observed Plasma Concentration (Tmax) [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Metformin PK Parameter Tmax [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Saxagliptin PK Parameter Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC[0-T]) [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Saxagliptin PK Parameter Maximum Observed Plasma Concentration (Cmax) [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Metformin PK Parameter T-HALF [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Secondary Outcome(s)

BMS-510849 PK Parameter AUC(0-T) [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs [Time Frame: AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days). SAEs collected from date of written consent until 30 days post discontinuation of dosing or subject's participation in the study.]

BMS-510849 PK Parameter Cmax [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

BMS-510849 PK Parameter T-Max [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Electrocardiogram (ECG), Vital Sign, and Physical Finding Abnormalities [Time Frame: At Screening (within 21 days of Study Day 1), Day -1 of Period 1 (ECG and Physical only), Day 1 of Periods 1-4 (Vitals only), at Study Discharge (Day 3 of Period 4) or Discontinuation]

Number of Participants With Marked Urinalysis Abnormalities [Time Frame: Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.]

AEs of Special Interest [Time Frame: AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days).]

BMS-510849 PK Parameter T-Half [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

BMS-510849 PK Parameter AUC(INF) [Time Frame: pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period]

Number of Participants With Marked Laboratory Abnormalities (MA) [Time Frame: Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.]

Secondary ID(s)

CV181-092

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/01/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00897390