Clinical trial NCT03488186: PK-PD Comparative Study of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers
Official title: A Randomized, Open Label, Parallel, Single and Multiple Doses Designed Clinical Study to Evaluate Comparative Pharmacokinetics (PK)-Pharmacodynamics (PD) After Oral Administration of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Effect of Drugs
Safety Issues
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Beijing Xuze Medical Technology Co., LTD.
First posted: 2018-04-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the relative PK-PD of Lansoprazole Capsules and Lansoprazole DR Capsules in healthy Chinese volunteers.

Detailed description: This is a randomized, open Label, parallel, single and multiple doses designed clinical trial. This study will determine the pharmacokinetics (PK), pharmacodynaimcs (PD) and safety after oral administration of an investigational Lansoprazole Capsules in healthy Chinese volunteers.

This study will enroll 24 healthy adults with 12 cases in each group (male : female=1:1).

Eligibility criteria: Inclusion Criteria:

* Subject who were healthy, adult, human beings within 18 and 60 years of age (both inclusive).
* Male (weight ≥50kg) or female (weight ≥45kg); Subject having a body mass index between 19.0 and 26.0 (both inclusive), calculated as weight in Kg/height in m2.
* Subject who totally understand the aim, procedure, benefits and adverse effects of this clinical trial, make decision by his/her free will, and sign a consent form to follow the progress;
* The participant could communicate well with investigator, comply with and finish the study according to the procedure.

Exclusion Criteria:

* Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
* Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
* Intake of over the counter (OTC) or prescribed medications or vitamins or any traditional medicine products for the last 14 days before first dosing.
* Has a special requirement for food and cannot adhere to a uniform diet or swallowing victims.
* Cannot tolerate placement of the pH probe;
* Venous puncture intolerable and/or blood phobia
* Abused of tea, coffee and caffeine-contained beverages; or taking caffeine/xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) for the last 48 hrs before first dosing.
* Habit of alcoholism; or frequent drinkers for the last 6 months before screening; or intake of any alcoholic products for the last 24 hrs before first dosing.
* Regular smoker who has a habit of smoking more than five cigarettes per day for the last 3 months and has difficulty in abstaining from smoking during sample collection period.
* Blood donation or blood loss ≥ 450 mL for the last 3 months before first dosing; or plan to donate blood or blood composition during the study or 3 months after the end of the study.
* Intake of any enzyme modifying food or beverages for the last 48 hrs before first dosing.
* Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study; or subjects declined to practice non-pharmacologic prevention of birth control during the study.
* Abused of drugs or Intake of drugs for the last 3 months before screening.
* Subjects who had participated in any other clinical investigation using experimental drug/medical instrument/diagnostic reagent in past 3 months before screening.
* Clinically significant abnormalities judged by investigators during screening test.
* Positive breath test result for H pylori at Screening;
* Confirmed positive in alcohol screening, smoking screening or selected drug of abuse.
* Human immunodeficiency virus(HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or syphilis positive.
* Other reasons for non-inclusion judged by investigator.

Primary outcomes:
measure: Pharmacokinetics Assessment
timeFrame: 16 hrs post-dose on day 1 and day 7.
measure: PD Assesment
timeFrame: 24 hrs post-dose on day 1 and day 7.
Secondary outcomes:
measure: Duration of intragastric pH within 24 hours postdose
timeFrame: 24 hrs after dose on day 1 and 7
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Lihua Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: