A bioequivalence study of Niloitinib 150mg capsule of Sobhan Oncology compared to Tasigna 150 mg capsule manufactured by Novartis in 24 healthy volunteers under fasting conditio
Not Applicable
- Conditions
- Investigation of bioequivalence of Nilotinib 150 mg capsule manufactured by Sobbhan Oncology company in comparison to the Tagigna150 mg capsule manufactured by Novartis company.
- Registration Number
- IRCT20220209053979N4
- Lead Sponsor
- Sobhan Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects
Body mass index (BMI) >18 but <30.
Laboratory parameter values must fall within the normal range
Exclusion Criteria
Smokers
History of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration of Nilotinib of Sobhan Oncology and Tasigna manufactured by Novartis Company. Timepoint: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 32, 48 h. Method of measurement: liquid chromatography mass spectrometry (LCMSMS).
- Secondary Outcome Measures
Name Time Method