In-Vivo Bioequivalence study of Naltrexone intramuscular injection in healthy Iranian volunteers
Not Applicable
Recruiting
- Conditions
- bioequivalence of test and reference drugs.
- Registration Number
- IRCT20200105046010N22
- Lead Sponsor
- ano Pajhoohan Pardis Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General health
Body Mass Index (BMI) between 18-28
Informed consent
Age between 18-60
Both male and female
Exclusion Criteria
Smoking
Pregnancy
Alcohol & Drug addiction
Hypersensitivity to the drug
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood concentration of the drug. Timepoint: 1,2,4,8,12,24,36,48,60,72,168,240,336,432,576,720 hours after intervention (drug receiving). Method of measurement: Liquid Chromatography with tandem mass spectroscopy detector.
- Secondary Outcome Measures
Name Time Method