IRCT20180620040164N57
Completed
未知
Bioequivalence study of empagliflozin 25 mg of Daro Darman Pars company in comparison with the reference sample of Jardiance made by Boehringer company.
Darou darman Pars Co.0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Darou darman Pars Co.
- Enrollment
- 24
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects (male) should be between 20\-45 years old.
- •subjects how have body mass index (BMI) Within 15% of normal range between 18\.5\-30 (Kg/m2\)
- •Subjects with normal vital signs.
- •Subjects who agree with patient consent form.
Exclusion Criteria
- •Subjects with known allergy to the products tested.
- •Subjects must not have a historical specific diseases or abnormal values in labratory tests and general clinical examination.
- •Chronic or acute diseases of the digestive system, such as diseases related to the esophagus, gastritis, peptic ulcer, intestinal inflammation, bleeding in the digestive tract, or digestive system surgery during the last three years.
- •Having problems with vascular system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, mental and metabolic system.
- •Performing surgery within 4 weeks before drug administration or at the time of clinical study.
- •Smoking more than 10 cigarettes per day, losing more than 500 ml of blood in less than 7 days.
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Bioequivalence study of Empagliflozin 25 mg tabletIRCT20200105046010N83kharazmi company24
Not yet recruiting
Not Applicable
Bioequivalence study of Empagliflozin 12.5 mg+ Metformin 1000 mg in 24 healthy male under fasting conditionsIRCT20180620040164N13ACtover Pharmaceutical Co26
Recruiting
Not Applicable
Bioequivalence study of Empagliflozin 25 mg tablet in 24 healthy male under fasting conditionsBioequivalence investigation of the generic Actoverco. Empagliflozin 25 mg tablet with brand Jardiance 25 mg tablet Boehringer..IRCT20180620040164N19Actover Pharmaceutical Co.24
Recruiting
Not Applicable
Bioequivalence of EmpaglifloziDetermination of plasma concentration of Empagliflozin 25 mg pharmaceutical product.IRCT20210201050197N5Shahid Beheshti University of Medical Sciences24
Completed
Not Applicable
Bioequivalence study of Empagliflozin ?? mg.IRCT20220111053692N18Tehran Chemie Pharmaceutical Company24