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

Chronic Gastritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658864
• Other study ID #: WHXH-lafutidine
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2016
• Last updated: January 19, 2016
• Start date: April 2005
• Est. completion date: June 2005

Study information

• Verified date: January 2016
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 27 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Gastritis

Intervention

Drug:
• lafutidine
comparison of different doses, sex and medication conditions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Peak concentration	one day	No
Primary	Area under the curve	Area under the curve - plasma concentration	one day	No
Primary	Clearance	Clearance	one day	No
Primary	Apparent volume of distribution-V	The apparent volume of distribution	one day	No
Secondary	Safety (adverse events)		six weeks	Yes