Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

NCT01093794 | Completed Phase 1 Results

• 2 other identifiers: 0431A-1222010_518
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and metformin.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve (AUC(0-t)) for Sitagliptin

  AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.

  baseline through 72 hours postdose

• Cmax for Sitagliptin and Metformin

  Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.

  baseline through 72 hours postdose

Study Arms (4)

1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850

EXPERIMENTAL

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * Co-administration of 50 mg sitagliptin and 500 mg metformin * sitagliptin/metformin 50 mg/500 mg FDC tablet * sitagliptin/metformin 50 mg/850 mg FDC tablet * Co-administration of 50 mg sitagliptin and 850 mg metformin

Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin; Drug: sitagliptin/metformin 50 mg/500 mg tablet; Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin; Drug: sitagliptin/metformin 50 mg/850 mg tablet

2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC

EXPERIMENTAL

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * sitagliptin/metformin 50 mg/500 mg FDC tablet * Co-administration of 50 mg sitagliptin and 850 mg metformin * Co-administration of 50 mg sitagliptin and 500mg metformin * sitagliptin/metformin 50 mg/850 mg FDC tablet

Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin; Drug: sitagliptin/metformin 50 mg/500 mg tablet; Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin; Drug: sitagliptin/metformin 50 mg/850 mg tablet

3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500

EXPERIMENTAL

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * Co-administration of 50 mg sitagliptin and 850 mg metformin * sitagliptin/metformin 50 mg/850 mg FDC tablet * sitagliptin/metformin 50 mg/500 mg FDC tablet * Co-administration of 50 mg sitagliptin and 500mg metformin

Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin; Drug: sitagliptin/metformin 50 mg/500 mg tablet; Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin; Drug: sitagliptin/metformin 50 mg/850 mg tablet

4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC

EXPERIMENTAL

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * sitagliptin/metformin 50 mg/850 mg FDC tablet * Co-administration of 50 mg sitagliptin and 500 mg metformin * Co-administration of 50 mg sitagliptin and 850 mg metformin * sitagliptin/metformin 50 mg/500 mg FDC tablet

Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin; Drug: sitagliptin/metformin 50 mg/500 mg tablet; Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin; Drug: sitagliptin/metformin 50 mg/850 mg tablet

Interventions

Co-administration of 50 mg sitagliptin and 500 mg metformin DRUG

Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.

1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850; 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC; 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500; 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC

sitagliptin/metformin 50 mg/500 mg tablet DRUG

Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850; 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC; 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500; 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC

Co-administration of 50 mg sitagliptin and 850 mg metformin DRUG

Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.

1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850; 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC; 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500; 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC

sitagliptin/metformin 50 mg/850 mg tablet DRUG

Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.

1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850; 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC; 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500; 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is of Chinese descent
• Subject is in good health
• Subject is a non-smoker

You may not qualify if:

• Subject has a history of stroke or chronic seizures
• Subject has a history of cancer
• Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Metformin; Tablets

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 26, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 28, 2015
• Results First Posted: June 27, 2011

Record last verified: 2015-07