Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fed Healthy Volunteers

May 9, 2023 updated by: Qilu Pharmaceutical Co., Ltd.
This study aimed to evaluate the pharmacokinetic characteristics of montelukast sodium oral thin films and the bioequivalence between oral thin films and chewable tablets in healthy chinese volunteers under fed condition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hainan
      • Haikou, Hainan, China, 570100
        • Haikou People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Fully understood and voluntarily signed the informed consent form
  • With high compliance
  • BMI 18.6-28.5 kg/m^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female

Exclusion Criteria:

  • Allergic to any component of study drugs, other leukotriene receptor antagonists, sulfonamides, or non-steroidal anti-inflammatory drugs
  • With clinically relevantly abnormal vital sign, examination, or clinically relevant disease
  • Had drug abuse within 3 months before screening or positive in drug of abuse test
  • With any routine use of drugs
  • Received major surgery within 6 months before study drug administration or planned to receive major surgery during study period
  • With average number of cigarettes smoked > 5/day within 3 months before screening or refused to suspend smoking from 24 hours before study drug administration throughout study period
  • With average alcohol consumption > 14 units/week within 6 months before screening or refused to suspend alcohol consumption from 24 hours before study drug administration throughout study period
  • With average tea, coffee, or other drink with caffeine consumption > 8*250 mL/day, or refused to suspend tea, coffee, other drink with caffeine, or grape fruit juice consumption from 24 hours before study drug administration throughout study period
  • Lost or donated blood > 200 mL within 3 months, or donated platelet > 24 U within 1 months before study drug administration
  • Received any drug within 14 days before study drug administration
  • Received any drug of other clinical trial within 3 months before study drug administration
  • Received any vaccine within 4 weeks before study drug administration
  • Planned for pregnancy within 3 months after informed consent form signed or refused to use adequate contraception (excluding contraceptive drug)
  • For female, pregnant, breastfeeding, received oral contraceptives within 30 days, or contraceptive injection or implant within 6 months before study drug administration
  • For pregnancy-capable female, had unprotected sexual contact within 14 days before study drug administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: TR
Administration order: montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water.
Drug: Montelukast sodium oral thin films with water (T)
Single-dose montelukast sodium oral thin film 5mg under fed condition with water 240 mL
Drug: Montelukast sodium chewable tablets with water (R)
Single-dose montelukast sodium chewable tablet 5mg under fed condition with water 240 mL
Other: RT
Administration order: montelukast sodium chewable tablets with water, montelukast sodium oral thin films with water.
Drug: Montelukast sodium oral thin films with water (T)
Single-dose montelukast sodium oral thin film 5mg under fed condition with water 240 mL
Drug: Montelukast sodium chewable tablets with water (R)
Single-dose montelukast sodium chewable tablet 5mg under fed condition with water 240 mL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 0-24 hours
The maximum plasma drug concentration
0-24 hours
AUC0-t
Time Frame: 0-24 hours
The area under the concentration-time curve from dosing to time t
0-24 hours
AUC0-∞
Time Frame: 0-24 hours
The area under the concentration-time curve extrapolated to infinity
0-24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: XiaoAi He, Haikou People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QL-XZ1-013-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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