Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets
1 other identifier
interventional
12
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2005
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 15, 2016
CompletedFirst Posted
Study publicly available on registry
January 20, 2016
CompletedJanuary 20, 2016
January 1, 2016
2 months
January 15, 2016
January 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Safety (adverse events)
six weeks
Study Arms (3)
10-mg group
EXPERIMENTALTwelve healthy subjects were administered a single oral dose of 10 mg lafutidine tablets in fasted state.
20-mg group
EXPERIMENTALTwelve healthy subjects were administered a single oral dose of 20 mg lafutidine tablets in fasted state.
40-mg group
EXPERIMENTALTwelve healthy subjects were administered a single oral dose of 40 mg lafutidine tablets in fasted state.
Interventions
comparison of different doses, sex and medication conditions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Weiyong Li, PhD
HUST/Union Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice director of the pharmcy department
Study Record Dates
First Submitted
January 15, 2016
First Posted
January 20, 2016
Study Start
April 1, 2005
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
January 20, 2016
Record last verified: 2016-01