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In-vivo Bioequivalence Test of Linalidomide capsules with brand drug (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb, UK)

Not Applicable
Recruiting
Conditions
Bio equivalence test.
Registration Number
IRCT20200105046010N53
Lead Sponsor
Actero middle east Pharm. 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 between18-28
Informed consent
Being at the age of 18-55 years old

Exclusion Criteria

Smoking
A history of cardiovascular disease
A history of liver & kidney disease
Pregnancy
Alcohol & Drug addiction
Hypersensitivity to the drug

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Plasma drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours after taking the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.
Secondary Outcome Measures
NameTimeMethod
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