Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer
- Registration Number
- NCT03488173
- Lead Sponsor
- First Affiliated Hospital of Zhejiang University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lansoprazole enteric-coated Capsules Lansoprazole capsules Lansoprazole enteric-coated Capsules 30 mg of Takeda Pharmaceutical Company Limited Lansoprazole Capsules Lansoprazole capsules Lansoprazole Capsules 30 mg of Beijing Sihuan Pharm
- Primary Outcome Measures
Name Time Method Pharmacokinetics Assessment 16 hrs post-dose on day 1. 1. Cmax: Maximum Observed Plasma Concentration for lansoprazole Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
\[Time Frame: 16 hours post-dose on Day 1\]
2. TmaxTime to Reach the Maximum Plasma Concentration \[Time Frame: 16 hours post-dose on Day 1\]
3. AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for lansoprazole AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity \[Time Frame: Time Frame: 16 hours post-dose on Day 1\]
4. AUC(0-16h): Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for lansoprazoleAUC(0-36h) is measure of area under the plasma concentration and time curve from Time 0 to 36 hours postdose.
\[Time Frame: 16 hours post-dose on Day 1\] model.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
First affiliated hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China