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Effect of DrugsPhase 1NCT03488186

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

A Phase 1 study testing Lansoprazole Capsules in people with Effect of Drugs and Safety Issues, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Effect of Drugs, Safety Issues
What is being tested?
Lansoprazole Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
19 Jul 2018to 24 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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.
  • Positive breath test result for H pylori at Screening;
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First affiliated hospital of Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: A Randomized, Open Label, Parallel, Single and Multiple Doses Designed Clinical Study to Evaluate Comparative Pharmacokinetics (PK)-Pharmacodynamics (PD) After Oral Administration of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers

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

Read the detailed description

This is a randomized, open Label, parallel, single and multiple doses designed clinical trial. This study will determine the pharmacokinetics (PK), pharmacodynaimcs (PD) and safety after oral administration of an investigational Lansoprazole Capsules in healthy Chinese volunteers.

This study will enroll 24 healthy adults with 12 cases in each group (male : female=1:1).

Being tested
Lansoprazole Capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lansoprazole CapsulesDrug

    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.

Study groups in NCT03488186
Study groupRoleWhat they receive
Lansoprazole CapsulesExperimentalLansoprazole Capsules of Beijing Sihuan Pharm, 30 mg
Receives: Drug: Lansoprazole Capsules
Lansoprazole enteric-coated CapsulesActive comparatorLansoprazole enteric-coated Capsules of Takeda Pharmaceutical Company Limited, 30 mg
Receives: Drug: Lansoprazole Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 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.

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

  2. 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

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

Secondary outcomes (1)

  1. Duration of intragastric pH within 24 hours postdose

    ean intragastric pH per hour Mean intragastric pH per hour Percentage time with the intragastric pH>4 during the first 4 hours Duration of intragastric pH>4 within first 4 hours postdose Percentage time with the intragastric pH>6 during the first 4 hours Duration of intragastric pH>6 within first 4 hours postdose Percentage of the participants with duration time of intragastric pH>4 over 12hNumbers of participants with duration time of intragastric pH>4 over 16h Percentage of the participants with duration time of intragastric pH>6 over 12h Numbers of participants with duration time of intragastric pH>6 over 16h intragastric pH<4 within 24 hours postdose

    Measured: 24 hrs after dose on day 1 and 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2018
  2. Study start19 Jul 2018
  3. Primary completion11 Oct 2018
  4. Study completion24 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03488186
Sponsor's protocol ID
LC00-018-02
Status last verified
Jul 2019
First submitted
18 Mar 2018
Last updated
16 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lansoprazole Capsules in people with Effect of Drugs and Safety Issues, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics Assessment (time frame: 16 hrs post-dose on day 1 and day 7.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03488186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.

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