PK-PD Comparative Study of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers

• Status: Completed
• Trial end date: 2019-04-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborator: Beijing Xuze Medical Technology Co., LTD.
• Treatments: Dexlansoprazole; Lansoprazole

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.