The objective of this study was to compare the relative PK-PD of Lansoprazole Capsules and Lansoprazole DR Capsules in healthy Chinese volunteers.
This is a randomized, open Label, parallel, single and multiple doses designed clinical trial. This study will determine the pharmacokinetics (PK), pharmacodynaimcs (PD) and safety after oral administration of an investigational Lansoprazole Capsules in healthy Chinese volunteers. This study will enroll 24 healthy adults with 12 cases in each group (male : female=1:1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
24 healthy volunteers will be recruited and randomized into 2 groups (12 for each). During the study session, subjects will receive T drug in group A or R drug in group B for 7 days in fasted condition.
First affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China
Pharmacokinetics Assessment
1. Cmax: Maximum Observed Plasma Concentration for lansoprazole Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. \[Time Frame: 16 hours post-dose on Day 1 and D7\] 2. TmaxTime to Reach the Maximum Plasma Concentration \[Time Frame: 16 hours post-dose on Day 1 and D7\] 3. AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for lansoprazole AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity \[Time Frame: Time Frame: 16 hours post-dose on Day 1 and D7\] model.
Time frame: 16 hrs post-dose on day 1 and day 7.
PD Assesment
1. Percentage time with the intragastric potential of hydrogen (pH)\<4 Duration of intragastric pH\<4 within 24 hours postdose 2. Percentage time with the intragastric pH\>6 Duration of intragastric pH\>6 within 24 hours postdose 3. The time of the intragastric pH reaching 4The time of intragastric pH reaching 4 after the last dos 4. The time of the intragastric pH reaching 6The time of intragastric pH reaching 6 after the last dose
Time frame: 24 hrs post-dose on day 1 and day 7.
Duration of intragastric pH within 24 hours postdose
ean intragastric pH per hour Mean intragastric pH per hour Percentage time with the intragastric pH\>4 during the first 4 hours Duration of intragastric pH\>4 within first 4 hours postdose Percentage time with the intragastric pH\>6 during the first 4 hours Duration of intragastric pH\>6 within first 4 hours postdose Percentage of the participants with duration time of intragastric pH\>4 over 12hNumbers of participants with duration time of intragastric pH\>4 over 16h Percentage of the participants with duration time of intragastric pH\>6 over 12h Numbers of participants with duration time of intragastric pH\>6 over 16h intragastric pH\<4 within 24 hours postdose
Time frame: 24 hrs after dose on day 1 and 7
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