IRCT20130313012810N27CompletedUnknown
Comparative bioequivalence study of the Naproxen 250 mg, tablet manufactured by Daana Pharma Company
Daana pharmaceutical company0 sites24 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 60 years (—)
- Sex
- All
Inclusion Criteria
- •The weight range of participating candidates should be between 60-100 kg
- •All candidates must be non-smokers
- •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 Naproxen 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)
Investigators
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