Comparative in vivo evaluation of 2 Sitagliptin 100 mg Tablet formulations

Not Applicable

• Conditions: Diabetes Mellitus.; Type 2 diabetes mellitus

• Registration Number: IRCT20180620040164N27
• Lead Sponsor: Actover Pharmaceutical Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Healthy subjects (male) between 20-45 years of age.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Subjects with normal vital signs.
Subjects who agree with patient consent form.
Body Mass Index (BMI) within 15% of normal range 18.5 and 30 (inclusive), calculated as kg/m2.

Exclusion Criteria

Hypersensitivity to the DPP-4 inhibitors, investigational drug and/or to inactive constituents.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period.
History of alcohol or drug abuse within 2 years before the start of the study.
Heavy drinker of caffeine, or caffeinated drinks.
A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.
Heavy drinker of grapefruit juice
Subjects on special diet (such as vegetarians)
Subjects who do exertional physical activity.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).

Secondary Outcome Measures

Name	Time	Method
AUC (Area Under the Concentration-Time Curve). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).