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COMPLETED
NCT03050164
PHASE1

Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions

Sponsor: Hunan Kelun Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2016-09-08

Completion Date

2016-11-04

Last Updated

2026-05-26

Healthy Volunteers

Yes

Interventions

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.