Study of absorption and elimination rate of Erlotinib 150 mg tablets in comparison with standard tablet of Erlotinib (Tarceva).

Not Applicable

Recruiting

• Conditions: ung and pancreatic cancer.

• Registration Number: IRCT20200407046981N7
• Lead Sponsor: Kimia pharmaceutical Co

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

The weight limit for each volunteer between 60-100 kg.
All volunteers must be non-smokers.
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics

Exclusion Criteria

Known hypersensitivity or idiosyncratic reaction to Erlotinib or any ingredients.
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg
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), AUC (Area Under the Concentration-Time Curve). Timepoint: At 0 (before intervention), 0.5? 1?1.5? 2? 2.5? 3? 5? 4? 6? 8? 12? 24? 48? 72 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS) and using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSSIntervention groups.