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COMPLETED
NCT03050177
PHASE1

Bioequivalence Study of Gefitinib Tablets Under Fed 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 fed conditions.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2016-09-01

Completion Date

2016-12-01

Last Updated

2026-05-26

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Gefitinib Tablet 250mg of Hunan Kelun

Single dose of Gefitinib Tablet 250mg of Hunan Kelun was administered under fed conditions after a 10-hour overnight fast.

DRUG

Iressa® Tablet 250mg of AZN

Single dose of Iressa® Tablet 250mg of AZN was administered under fed conditions after a 10-hour overnight fast.