Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer

NCT03488173 | Completed Phase 1

• 1 other identifier: LC00-018-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Drugs; Safety Issues

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics Assessment

  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.

  16 hrs post-dose on day 1.

Study Arms (2)

Lansoprazole Capsules

EXPERIMENTAL

Lansoprazole Capsules 30 mg of Beijing Sihuan Pharm

Drug: Lansoprazole capsules

Lansoprazole enteric-coated Capsules

ACTIVE COMPARATOR

Lansoprazole enteric-coated Capsules 30 mg of Takeda Pharmaceutical Company Limited

Drug: Lansoprazole capsules

Interventions

Lansoprazole capsules DRUG

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.

Lansoprazole Capsules; Lansoprazole enteric-coated Capsules

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Beijing Xuze Medical Technology Co., LTD.: collaborator

Study Sites (1)

First affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Interventions

Lansoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lihua Wu, Doctor

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Jian Liu, Master

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 4, 2018
• Study Start: April 23, 2018
• Primary Completion: July 19, 2018
• Study Completion: April 24, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)