Bioequivalence Study of Gefitinib Tablets Under Fed Conditions

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

September 1, 2016

Primary Completion Date

December 1, 2016

Study Completion Date

December 1, 2016

Conditions
Healthy
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.

All Listed Sponsors
lead

Hunan Kelun Pharmaceutical Co., Ltd.

INDUSTRY