This is a single center, open-label, multiple-dose phase 1 clinical trial. This study will determine the pharmacokinetics (PK), pharmacodynamics (PD), safety and side-effect profile of an investigational dexlansoprazole injection after multiple intravenous administration in healthy Chinese adults.
This is a single center, open-label, multiple-dose clinical trial. 5 dosing groups were designed, including 15mg q12h,30mg q12h,15mg qd,30mg qd in dexlansoprazole treatment arm for 5 days, and 30 mg q12h in an active comparator, lansoprazole, treatment arm for 5 days. The study will enroll approximately 70 participants with 14 cases in each group. Participants will make 3 visits to the clinic including 8-day of confinement to the clinic.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days
30 mg q12h for 5 days.
First affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGPercentage time with the intragastric potential of hydrogen (pH)>4
Duration of intragastric pH\>4 within 24 hours postdose
Time frame: 24 hours post-dose on Day 5
Percentage time with the intragastric pH>6
Duration of intragastric pH\>6 within 24 hours postdose
Time frame: 24 hours post-dose on Day 5
The time of the intragastric pH reaching 4
The time of intragastric pH reaching 4 after the last dose
Time frame: 12 hours post-dose on Day 5
The time of the intragastric pH reaching 6
The time of intragastric pH reaching 6 after the last dose
Time frame: 12 hours post-dose on Day 5
Mean intragastric pH
Mean intragastric pH
Time frame: 24 hours post-dose on Day 5
Mean intragastric pH per hour
Mean intragastric pH per hour
Time frame: 24 hours post-dose on Day 5
Percentage time with the intragastric pH>4 during the first 4 hours
Duration of intragastric pH\>4 within first 4 hours postdose
Time frame: 4 hours post-dose on Day 5
Percentage time with the intragastric pH>6 during the first 4 hours
Duration of intragastric pH\>6 within first 4 hours postdose
Time frame: 4 hours post-dose on Day 5
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Percentage of the participants with duration time of intragastric pH>4 over 12h
Numbers of participants with duration time of intragastric pH\>4 over 12h
Time frame: 12 hours post-dose on Day 5
Percentage of the participants with duration time of intragastric pH>6 over 12h
Numbers of participants with duration time of intragastric pH\>6 over 12h
Time frame: 12 hours post-dose on Day 5
Cmax on day 1
Maximum observed plasma concentration for dexlansoprazole
Time frame: 12 hours post-dose on Day 5
Cmax on day 5
Maximum observed plasma concentration for dexlansoprazole
Time frame: 12 hours post-dose on Day 5
Area under the plasma concentration-time curve (AUC) on day 1
AUC from time 0 to the time of the last quantifiable concentration on day 1
Time frame: 12 hours post-dose on Day 5
AUC(0-12h) on day 5
AUC from time 0 to the time of the last quantifiable concentration on day 5
Time frame: 12 hours post-dose on Day 5
AUC(0-inf) on day 1
AUC from time 0 to extrapolated to infinity on day 1
Time frame: 12 hours post-dose on Day 5
AUC(0-inf) on day 5
AUC from time 0 to extrapolated to infinity on day 5
Time frame: 12 hours post-dose on Day 5