Single Dose Glumetinib in Healthy Chinese Male Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

March 2, 2021

Primary Completion Date

May 21, 2021

Study Completion Date

September 30, 2021

Conditions
Healthy Volunteers
Interventions
DRUG

Glumetinib

"Fasting: Subjects are fasted overnight (at least 10 hours before administration) and receive Glumetinib tablets with 240 mL warm water the next morning.~Fed (high-fat meal/low-fat meal): Following an overnight fast for at least 10 hours, subjects finished a high-fat meal, or a low-fat meal within 30 minutes the next morning (eat up all meals). Glumetinib tablets are orally administered by subjects with 240 mL warm water on 30 minutes after starting the meal. Water is allowed as desired except for 1 hour before and 2 hours after administration (including the meal), and no more than 500 mL of water will be consumed including the water intake during the high-fat meals or low-fat meals, and the water for administration. The subjects will be fasted for at least 4 hours after administration, and then have dinner approximately 9 hours after administration."

Trial Locations (1)

200020

Zhongshan Hositpal, Shanghai

Sponsors
All Listed Sponsors
lead

Haihe Biopharma Co., Ltd.

INDUSTRY