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

NCT03488186 | Completed Phase 1

• 1 other identifier: LC00-018-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Effect of Drugs; Safety Issues

Outcome Measures

Primary Outcomes (2)

• 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. \[Time Frame: 16 hours post-dose on Day 1 and D7\] 2. TmaxTime to Reach the Maximum Plasma Concentration \[Time Frame: 16 hours post-dose on Day 1 and D7\] 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 \[Time Frame: Time Frame: 16 hours post-dose on Day 1 and D7\] model.

  16 hrs post-dose on day 1 and day 7.

• PD Assesment

  1. Percentage time with the intragastric potential of hydrogen (pH)\<4 Duration of intragastric pH\<4 within 24 hours postdose 2. Percentage time with the intragastric pH\>6 Duration of intragastric pH\>6 within 24 hours postdose 3. The time of the intragastric pH reaching 4The time of intragastric pH reaching 4 after the last dos 4. The time of the intragastric pH reaching 6The time of intragastric pH reaching 6 after the last dose

  24 hrs post-dose on day 1 and day 7.

Secondary Outcomes (1)

• Duration of intragastric pH within 24 hours postdose

  24 hrs after dose on day 1 and 7

Study Arms (2)

Lansoprazole Capsules

EXPERIMENTAL

Lansoprazole Capsules of Beijing Sihuan Pharm, 30 mg

Drug: Lansoprazole Capsules

Lansoprazole enteric-coated Capsules

ACTIVE COMPARATOR

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

Drug: Lansoprazole Capsules

Interventions

Lansoprazole Capsules DRUG

24 healthy volunteers will be recruited and randomized into 2 groups (12 for each). During the study session, subjects will receive T drug in group A or R drug in group B for 7 days in fasted condition.

Lansoprazole Capsules; Lansoprazole enteric-coated Capsules

Eligibility Criteria

• Age: 18 Years - 45 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.
• 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.

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

Study Design

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

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: April 4, 2018
• Study Start: July 19, 2018
• Primary Completion: October 11, 2018
• Study Completion: April 24, 2019
• Last Updated: August 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)