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

Sponsor

Wuhan Union Hospital, China (Other)

Overall Status

Completed

CT.gov ID

NCT02658864

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Gastritis	Drug: lafutidine	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 10-mg group

Twelve healthy subjects were administered a single oral dose of 10 mg lafutidine tablets in fasted state.

Drug: lafutidine

comparison of different doses, sex and medication conditions

Experimental: 20-mg group

Twelve healthy subjects were administered a single oral dose of 20 mg lafutidine tablets in fasted state.

Drug: lafutidine

comparison of different doses, sex and medication conditions

Experimental: 40-mg group

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

Outcome Measures

Primary Outcome Measures

Cmax [one day]
Peak concentration
Area under the curve [one day]
Area under the curve - plasma concentration
Clearance [one day]
Clearance
Apparent volume of distribution-V [one day]
The apparent volume of distribution

Secondary Outcome Measures

Safety (adverse events) [six weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 27 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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