Bioequivalence study of VITALOPHAGE 500mg tablet of Vitabiotics Pharmed Co., IRA
Not Applicable
- Conditions
- Diabetes.Z79. 84Long term (current) use of oral hypoglycemic drugs
- Registration Number
- IRCT20190706044111N31
- Lead Sponsor
- Vitabiotix Pharmed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Aged between 18 - 50 years
Body weight between 50 – 100 kg
Having good health on the basis of medical history and physical & clinical examination
Understand the procedures and give written informed consent
Exclusion Criteria
Subject had undergone surgery of the gastro-intestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment.
?Subject had a history of drug or alcohol abuse.
Subject who smokes more than 10 cigarettes per day.
Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method