Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

April 23, 2018

Primary Completion Date

July 19, 2018

Study Completion Date

April 24, 2019

Conditions
Effect of DrugsSafety Issues
Interventions
DRUG

Lansoprazole capsules

"Test 1: 30 healthy volunteers will be included and randomized into 3 groups (10 for each). During the study session, subjects will receive a single dose of Lansoprazole capsules 30 mg in sequence of T-R-R in group A; R-T-R in group B; and R-R-T in group C.~Test 2: 12 healthy volunteers will be recruited and randomized to 2 groups (6 for each). Subjects in group A will receive a single dose of experimental drug in sequence of fast-fed condition; while in group B, subjects will receive the same dose and drug but in fed-fast order."

Trial Locations (1)

310003

First affiliated hospital of Zhejiang University, Hangzhou

All Listed Sponsors
collaborator

Beijing Xuze Medical Technology Co., LTD.

OTHER

lead

First Affiliated Hospital of Zhejiang University

OTHER

NCT03488173 - Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer | Biotech Hunter | Biotech Hunter