Budesonide tablet bioequivalence
- Conditions
- Bioequivalence study in healthy volunteers.
- Registration Number
- IRCT20130313012810N23
- Lead Sponsor
- Tasnim pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
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
History of allergic or adverse reaction to Budesonide or any similar product
Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg
Smokers
Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method