Bioequivalence of a New Generic Formulation of Sunitinib 50 mg capsules versus Sutent in Healthy Volunteers under Fasting Conditions

Not Applicable

Not yet recruiting

• Conditions: For the treatment of renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor.

• Registration Number: IRCT20200407046981N2
• Lead Sponsor: Kimia pharmaceutical Co

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

The weight limit for each volunteer is between 60 and 100 kg.
Only non-smokers are allowed to participate.
They must be healthy in terms of liver and kidney status, respiratory system, and other general health characteristics that will be assessed.

Exclusion Criteria

Known hypersensitivity or idiosyncratic reaction to Sunitinib or any ingredients.
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of TB, epilepsy, asthma (during past 5 years), DM, psychosis or glaucoma.
Regular smoker who smokes more than ten cigarettes daily.
Taking any medicine during two week before dosing

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 0.5, 1.5, 3, 4.5 , 6, 8, 12, 18, 24, 36 & 48 hour after dosing. Method of measurement: HPLC/Mass.

Secondary Outcome Measures

Name	Time	Method
AUC (Area Under the Concentration-Time Curve). Timepoint: During 2 months after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.