NCT03050164

Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions

Single-dose, Open-label, Randomized, 2-way Crossover Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions in Chinese Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Hunan Kelun Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence Study. During each session, the subjects will be administered a single dose of 250mg Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan Kelun or one Iressa® Tablet 250mg of AstraZeneca) under fasting conditions.

Detailed description

An Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence Study. During each session, the subjects were randomly assigned in a 1:1 ratio to receive a single 250-mg dose of either the test formulation(Hunam Kelun) or the reference formulation(Iressa® Astrazeneca), and vice versa, with a 21-day washout period between administration periods.

Conditions

• Bioequivalence Study

Interventions

Type	Name	Description
DRUG	Gefitinib Tablet 250mg of Hunan Kelun	Single dose of Gefitinib Tablet 250mg of Hunan Kelun was administered after a 10-hour overnight fast.
DRUG	Iressa® Tablet 250mg of AZN	Single dose of Iressa® Tablet 250mg of AZN was administered after a 10-hour overnight fast.

Timeline

• Start date: 2016-09-08
• Primary completion: 2016-11-04
• Completion: 2016-11-04
• First posted: 2017-02-10
• Last updated: 2017-02-10