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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658864
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Weiyong Li, Wuhan Union Hospital, China

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Gastritis Drug: lafutidine Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets in Healthy Chinese Subjects
Study Start Date : April 2005
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Cmax [ Time Frame: one day ]
    Peak concentration

  2. Area under the curve [ Time Frame: one day ]
    Area under the curve - plasma concentration

  3. Clearance [ Time Frame: one day ]
    Clearance

  4. Apparent volume of distribution-V [ Time Frame: one day ]
    The apparent volume of distribution


Secondary Outcome Measures :
  1. Safety (adverse events) [ Time Frame: six weeks ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 27 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658864


Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
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Principal Investigator: Weiyong Li, PhD HUST/Union Hospital
More Information
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Responsible Party: Weiyong Li, vice director of the pharmcy department, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT02658864    
Other Study ID Numbers: WHXH-lafutidine
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by Weiyong Li, Wuhan Union Hospital, China:
lafutidine tablet
pharmacokinetics
food
safety
healthy subjects
Additional relevant MeSH terms:
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Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Lafutidine
Anti-Ulcer Agents
 Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs