IRCT20130313012810N22
Completed
未知
Bioequivalence study of Empagliflozin 5 mg/ Metformin 1000 mg film coated tablet manufactured by Modava Pharmaceutical Company
Modava Pharmaceutical Company0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Modava Pharmaceutical Company
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The weight range of participating candidates should be between 60\-100 kg
- •Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?\-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose
- •Volunteers who have agreed to an informed consent form
- •All candidates should not consume caffeine\-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw
Exclusion Criteria
- •History of allergic or adverse reaction to Empagliflozin/Metformin or any similar product
- •Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg
- •Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s)
Outcomes
Primary Outcomes
Not specified
Similar Trials
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 Study of Empagliflozin/Metformin 5/500 mgThis study is performed on healthy volunteers and drug concentration in plasma is determined..IRCT20200105046010N95Kharazmi Pharmacy24
Recruiting
Not Applicable
In-vivo Bioequivalence Test of Empagliflozin-Metformin tablets with brand drug (Synjardy® 25/1000 mg, Boehringer Ingelheim, Germany)Bio equivalence test.IRCT20200105046010N60Pars Darou Pharmaceutical Company24
Recruiting
Not Applicable
Investigating the in vivo bioequivalence of Empagliflozin /Metformin tabletIRCT20210519051345N31Tabriz University of Medical Sciences24