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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Lafutidine

Criteria

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