Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets in Healthy Chinese Subjects

Conditions
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Chronic Gastritis

Intervention / Treatment
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* Drug: lafutidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index between19 and 24 kg/m2 negative for HIV and hepatitis B had no clinical important findings on health tests thorax radiography and ECG with no abnormalities normal blood pressure values heart rate Exclusion Criteria: any drug treatment within 2 weeks before starting the study participation in another clinical study within the previous 3 months alcoholism and smoking pregnancy breast-feeding hypocalcemia blood donation or participation in other clinical trials within 3 months before enrollment in the study sitting blood pressure <80/50 mm Hg or >140/100 mm Hg A ventricular rate <60 beats/min or >100 beats/min at rest

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 27 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10-mg group<br>Twelve healthy subjects were administered a single oral dose of 10 mg lafutidine tablets in fasted state. | Drug: lafutidine<br>* comparison of different doses, sex and medication conditions<br>|
| Experimental: 20-mg group<br>Twelve healthy subjects were administered a single oral dose of 20 mg lafutidine tablets in fasted state. | Drug: lafutidine<br>* comparison of different doses, sex and medication conditions<br>|
| Experimental: 40-mg group<br>Twelve healthy subjects were administered a single oral dose of 40 mg lafutidine tablets in fasted state. | Drug: lafutidine<br>* comparison of different doses, sex and medication conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Peak concentration | one day | 
| Area under the curve | Area under the curve - plasma concentration | one day | 
| Clearance | Clearance | one day | 
| Apparent volume of distribution-V | The apparent volume of distribution | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) |  | six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lafutidine tablet, pharmacokinetics, food, safety, healthy subjects