Healthy VolunteersNCT05528198
Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fasted Healthy Volunteers
A study testing Montelukast sodium oral thin films without water (A), Montelukast sodium oral thin films with water (B) and Montelukast sodium chewable tablets with water (C) in people with Healthy Volunteers, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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 fasted condition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Montelukast sodium oral thin films without water (A), Montelukast sodium oral thin films with water (B) and Montelukast sodium chewable tablets with water (C)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2018to 14 May 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Three-period, Three-sequence, Crossover, Single-dose Bioequivalence Study of Montelukast Sodium Oral Thin Films in Healthy Chinese Volunteers Under Fasted Condition
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 fasted condition.
- Conditions
- Healthy Volunteers
- Being tested
- Montelukast sodium oral thin films without water (A), Montelukast sodium oral thin films with water (B), Montelukast sodium chewable tablets with water (C)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast sodium oral thin films without water (A)Drug
Single-dose montelukast sodium oral thin film 5mg under fasted condition without water
Montelukast sodium oral thin films with water (B)Drug
Single-dose montelukast sodium oral thin film 5mg under fasted condition with water 240 mL
Montelukast sodium chewable tablets with water (C)Drug
Single-dose montelukast sodium chewable tablet 5mg under fasted condition with water 240 mL
| Study group | Role | What they receive |
|---|---|---|
| ABC | Other | Administration order: montelukast sodium oral thin films without water, montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water. Receives: Drug: Montelukast sodium oral thin films without water (A); Drug: Montelukast sodium oral thin films with water (B); Drug: Montelukast sodium chewable tablets with water (C) |
| BCA | Other | Administration order: montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water. Receives: Drug: Montelukast sodium oral thin films without water (A); Drug: Montelukast sodium oral thin films with water (B); Drug: Montelukast sodium chewable tablets with water (C) |
| CAB | Other | Administration order: montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water, montelukast sodium oral thin films with water. Receives: Drug: Montelukast sodium oral thin films without water (A); Drug: Montelukast sodium oral thin films with water (B); Drug: Montelukast sodium chewable tablets with water (C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
The maximum plasma drug concentration
Measured: 0-24 hours
AUC0-t
The area under the concentration-time curve from dosing to time t
Measured: 0-24 hours
AUC0-∞
The area under the concentration-time curve extrapolated to infinity
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start28 Dec 2018
- Primary completion14 May 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoai He, Principal investigator, Haikou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528198
- Sponsor's protocol ID
- QL-XZ1-013-01
- Status last verified
- May 2023
- First submitted
- 1 Sep 2022
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu G, Wang L, Han S, Peng H, Tong M, Gu X, Hu H, Wang Y, Lv Z, He X. Pharmacokinetics and bioequivalence study of montelukast sodium oral soluble film and chewable tablet in healthy Chinese volunteers: randomized trials under fasting and fed conditions. Ann Transl Med. 2023 Jan 31;11(2):93. doi: 10.21037/atm-22-6485.
PubMed 36819512
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Three-period, Three-sequence, Crossover, Single-dose Bioequivalence Study of Montelukast Sodium Oral Thin Films in Healthy Chinese Volunteers Under Fasted Condition
- ClinicalTrials.gov ID
- NCT05528198
- Acronym / sponsor ID
- QL-XZ1-013-01
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 fasted condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABC | Other | Drug: Montelukast sodium oral thin films without water (A), Drug: Montelukast sodium oral thin films with water (B), Drug: Montelukast sodium chewable tablets with water (C)Administration order: montelukast sodium oral thin films without water, montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water. |
| BCA | Other | Drug: Montelukast sodium oral thin films without water (A), Drug: Montelukast sodium oral thin films with water (B), Drug: Montelukast sodium chewable tablets with water (C)Administration order: montelukast sodium oral thin films with water, montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water. |
| CAB | Other | Drug: Montelukast sodium oral thin films without water (A), Drug: Montelukast sodium oral thin films with water (B), Drug: Montelukast sodium chewable tablets with water (C)Administration order: montelukast sodium chewable tablets with water, montelukast sodium oral thin films without water, montelukast sodium oral thin films with water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukast sodium oral thin films without water (A)Single-dose montelukast sodium oral thin film 5mg under fasted condition without water | Drug | ABC, BCA, CAB |
| Montelukast sodium oral thin films with water (B)Single-dose montelukast sodium oral thin film 5mg under fasted condition with water 240 mL | Drug | ABC, BCA, CAB |
| Montelukast sodium chewable tablets with water (C)Single-dose montelukast sodium chewable tablet 5mg under fasted condition with water 240 mL | Drug | ABC, BCA, CAB |
Primary outcome
Cmax
Time frame: 0-24 hours
The maximum plasma drug concentration
AUC0-t
Time frame: 0-24 hours
The area under the concentration-time curve from dosing to time t
AUC0-∞
Time frame: 0-24 hours
The area under the concentration-time curve extrapolated to infinity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 36819512Zhu G, Wang L, Han S, Peng H, Tong M, Gu X, Hu H, Wang Y, Lv Z, He X. Pharmacokinetics and bioequivalence study of montelukast sodium oral soluble film and chewable tablet in healthy Chinese volunteers: randomized trials under fasting and fed conditions. Ann Transl Med. 2023 Jan 31;11(2):93. doi: 10.21037/atm-22-6485.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoai He principal investigator
Haikou People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montelukast sodium oral thin films without water (A), Montelukast sodium oral thin films with water (B) and Montelukast sodium chewable tablets with water (C) in people with Healthy Volunteers, run by Qilu Pharmaceutical Co., Ltd. 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 3 inclusion and 15 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 11 May 2023. 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.
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?
Cmax (time frame: 0-24 hours). The study lists 3 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 NCT05528198, which also lists 1 linked publication.
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 11 May 2023.