A Phase 1 interventional study of lafutidine in Chronic Gastritis, sponsored by Wuhan Union Hospital, China. Completed. Open to participants aged 19 Years to 27 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-20.
Sponsored by Wuhan Union Hospital, China · Phase 1, Interventional, and Basic science
This study was to evaluate the pharmacokinetics of single and multiple doses of oral lafutidine tablets and the effect of food on pharmacokinetics in healthy Chinese subjects. The tolerability and the effect of sex on the pharmacokinetic properties were also evaluated to acquire more pharmacokinetic information.
The study of single-dose was randomized, three-period, crossover. And in this study, 12 subjects were randomly assigned to 3 dose groups and received a single dose of 10mg, 20mg and 40mg lafutidine tablets. The washout period was 7 calendar days. In the multiple-dose, 12 subjects took lafutidine tablets of 10 mg twice a day for 6 consecutive days. In the food-effect study, 12 subjects were randomly assigned to 2 groups. One group received a single dose of 10mg lafutidine tablets under fasted condition, while the other were in fed condition. The drug administrations were separated by a wash-out period of seven calendar days. In each study group, the male and the female are both in half of the subjects. Using a liquid chromatography tandem mass spectrometry (LC/MS/MS) method to determine the plasma concentration of lafutidine. Pharmacokinetic parameters were calculated using the single compartment model.
196 studies on the registry are indexed under Gastritis; 42 are open to participants now.
This study's enrollment of 12 is below the median of 200 across 113 interventional studies indexed under Gastritis.
Browse Gastritis studies →Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Twelve healthy subjects were administered a single oral dose of 10 mg lafutidine tablets in fasted state.
Drug: lafutidine
Twelve healthy subjects were administered a single oral dose of 20 mg lafutidine tablets in fasted state.
Drug: lafutidine
Twelve healthy subjects were administered a single oral dose of 40 mg lafutidine tablets in fasted state.
Drug: lafutidine
comparison of different doses, sex and medication conditions
Cmax
Peak concentration
Time frame: one day
Area under the curve
Area under the curve - plasma concentration
Time frame: one day
Clearance
Clearance
Time frame: one day
Apparent volume of distribution-V
The apparent volume of distribution
Time frame: one day
Safety (adverse events)
Time frame: six weeks
No study locations are listed for this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Wuhan Union Hospital, China