Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer

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.

Study Overview

• Status: Completed
• Conditions: Safety Issues; Effect of Drugs
• Intervention / Treatment: Drug: Lansoprazole capsules

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • First Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lansoprazole Capsules; Lansoprazole Capsules 30 mg of Beijing Sihuan Pharm	Drug: Lansoprazole capsules; Test 1: 30 healthy volunteers will be included and randomized into 3 groups (10 for each). During the study session, subjects will receive a single dose of Lansoprazole capsules 30 mg in sequence of T-R-R in group A; R-T-R in group B; and R-R-T in group C. Test 2: 12 healthy volunteers will be recruited and randomized to 2 groups (6 for each). Subjects in group A will receive a single dose of experimental drug in sequence of fast-fed condition; while in group B, subjects will receive the same dose and drug but in fed-fast order.
ACTIVE_COMPARATOR: Lansoprazole enteric-coated Capsules; Lansoprazole enteric-coated Capsules 30 mg of Takeda Pharmaceutical Company Limited	Drug: Lansoprazole capsules; Test 1: 30 healthy volunteers will be included and randomized into 3 groups (10 for each). During the study session, subjects will receive a single dose of Lansoprazole capsules 30 mg in sequence of T-R-R in group A; R-T-R in group B; and R-R-T in group C. Test 2: 12 healthy volunteers will be recruited and randomized to 2 groups (6 for each). Subjects in group A will receive a single dose of experimental drug in sequence of fast-fed condition; while in group B, subjects will receive the same dose and drug but in fed-fast order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics Assessment	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]; TmaxTime to Reach the Maximum Plasma Concentration [Time Frame: 16 hours post-dose on Day 1]; 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]; 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.	16 hrs post-dose on day 1.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborators: Beijing Xuze Medical Technology Co., LTD.
• Investigators: Principal Investigator: Jian Liu, Master, First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2018
• Primary Completion (ACTUAL): July 19, 2018
• Study Completion (ACTUAL): April 24, 2019

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (ACTUAL): April 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: LC00-018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No