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Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer

NCT03488173•First Affiliated Hospital of Zhejiang University

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

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

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.
+7 more criteria

Locations (1)

First affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

April 23, 2018

Primary Completion Date

July 19, 2018

Completion Date

April 24, 2019

Last Updated

August 15, 2019

Enrollment

ACTUAL participants

Conditions

Effect of DrugsSafety Issues

Interventions

Lansoprazole capsules

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer

Inclusion Criteria

Exclusion Criteria

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