Clinical trial NCT03488173: Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer
Official title: Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer
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: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare pharmacokinetic of Lansoprazole Capsules 30 mg with Lansoprazole Capsules of Takeda 30 mg in healthy adult human subjects.

Detailed description: i. randomized, open label, single-dose, two-treatment, three-period,partial replicate pharmacokinetic study of Lansoprazole 30 mg Capsules of Beijing Sihuan Pharm, comparing with that of Lansoprazole enteric-coated Capsules 30 mg of Takeda Pharmaceutical Company Limited in healthy, adult, human subjects under fasting conditions.

ii. randomized, open label, single dose, two-period, pharmacokinetic study of Lansoprazole 30 mg Capsules of Beijing Sihuan Pharm in healthy, adult, human subjects under fasting/fed conditions.

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.
* 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.
* 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.
Secondary outcomes:
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
affiliation: First Affiliated Hospital of Zhejiang University
name: Jian Liu, Master
role: PRINCIPAL_INVESTIGATOR
References: