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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Gastritis
• Intervention / Treatment: Drug: lafutidine

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 27 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Peak concentration	one day
Area under the curve	Area under the curve - plasma concentration	one day
Clearance	Clearance	one day
Apparent volume of distribution-V	The apparent volume of distribution	one day

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety (adverse events)	six weeks

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Weiyong Li, PhD, HUST/Union Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (ACTUAL): June 1, 2005
• Study Completion (ACTUAL): June 1, 2005

Study Registration Dates

• First Submitted: January 15, 2016
• First Submitted That Met QC Criteria: January 19, 2016
• First Posted (ESTIMATE): January 20, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: safety; pharmacokinetics; healthy subjects; food; lafutidine tablet
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Lafutidine
• Other Study ID Numbers: WHXH-lafutidine