NCT02658864

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 19 Years – 27 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Gastritis

Interventions

Type	Name	Description
DRUG	lafutidine	comparison of different doses, sex and medication conditions

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2016-01-20
• Last updated: 2016-01-20