Bioequivalence study of vaginal progesterone suppository 400 mg
Not Applicable
Recruiting
- Conditions
- ---.
- Registration Number
- IRCT20230222057495N4
- Lead Sponsor
- Ati Pharmed pharmaceutical company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 24
Inclusion Criteria
A healthy, non-pregnant and non-lactating female volunteer, who at the time of drug administration should be on the 4th-6th day of her menstrual cycle so that the amount of endogenous progesterone is at its minimum.
Be between 18 and 45 years old.
All candidates must be non-smokers.
Candidate's body mass index (BMI) should be less than 30 kg/m2.
Exclusion Criteria
Blood pressure lower than 90/60 mm Hg or higher than 140/90 mm Hg
Smokers who use more than 10 cigarettes a day
Consumption of any drugs, alcohol or tobacco products within 2 weeks before receiving the drug
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax. Timepoint: Once 15 minutes before the start of drug administration and then at time intervals: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 30, 48, 56 and 72 hours after administration. , will be done. Method of measurement: HPLC with UV detector.
- Secondary Outcome Measures
Name Time Method