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

Phase 1

Completed

• Conditions: Chronic Gastritis
• Interventions: Drug: lafutidine

• Registration Number: NCT02658864
• Lead Sponsor: Wuhan Union Hospital, China

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.

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 Timeline

• Study Start: 2005-04
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Status Verified: 2016-01
• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-19
• Last Update Submitted: 2016-01-19
• Study First Posted: 2016-01-20
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10-mg group	lafutidine	Twelve healthy subjects were administered a single oral dose of 10 mg lafutidine tablets in fasted state.
20-mg group	lafutidine	Twelve healthy subjects were administered a single oral dose of 20 mg lafutidine tablets in fasted state.
40-mg group	lafutidine	Twelve healthy subjects were administered a single oral dose of 40 mg lafutidine tablets in fasted state.

Primary Outcome Measures

Name	Time	Method
Area under the curve	one day	Area under the curve - plasma concentration
Clearance	one day	Clearance
Cmax	one day	Peak concentration
Apparent volume of distribution-V	one day	The apparent volume of distribution

Secondary Outcome Measures

Name	Time	Method
Safety (adverse events)	six weeks