Bioequivalence study of Empagliflozin 25 mg tablet in 24 healthy male under fasting conditions

Not Applicable

Recruiting

• Conditions: Bioequivalence investigation of the generic Actoverco. Empagliflozin 25 mg tablet with brand Jardiance 25 mg tablet Boehringer..

• Registration Number: IRCT20180620040164N19
• Lead Sponsor: Actover Pharmaceutical Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

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

Inclusion Criteria

Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2
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.

Exclusion Criteria

Subjects with known allergy to the products tested.
Subjects with chronic or active gastrointestinal diseases such as esophageal diseases, gastritis, gastric ulcers, enteritis, active gastrointestinal bleeding or got any digestive tract surgery within three years.
Subject with a history of circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities.
Those who have undergone surgery during the first four weeks before the trial or are scheduled to perform surgery during the study period.
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, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
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.

Study & Design

• Study Type: interventional
• Study Design: Not specified