Who is sponsoring NCT05528198?

NCT05528198 is sponsored by Qilu Pharmaceutical Co., Ltd..

What drugs are being tested in NCT05528198?

Interventions in NCT05528198: Montelukast sodium oral thin films without water (A), Montelukast sodium oral thin films with water (B), Montelukast sodium chewable tablets with water (C).

What condition does NCT05528198 study?

NCT05528198 studies Healthy Volunteers.

Is NCT05528198 still recruiting?

NCT05528198 is currently completed. Last updated 11 May 2023.

Last reviewed 2023-05-11 · How we verify

NCT05528198

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 11 May 2023

What this trial tests

NA trial testing Montelukast sodium oral thin films without water (A) in Healthy Volunteers in 30 participants. Completed in 14 May 2019.

Timeline

28 December 2018

Primary endpoint
14 May 2019

14 May 2019

Quick facts

Lead sponsor	Qilu Pharmaceutical Co., Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	28 December 2018
Primary completion	14 May 2019
Estimated completion	14 May 2019
Sites	1 location across China

Drugs / interventions tested

Montelukast sodium oral thin films without water (A) — full drug profile →
Montelukast sodium oral thin films with water (B) — full drug profile →
Montelukast sodium chewable tablets with water (C) — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Qilu Pharmaceutical Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacokinetics and bioequivalence study of montelukast sodium oral soluble film and chewable tablet in healthy Chinese volunteers: randomized trials under fasting and fed conditions.
Zhu G, Wang L, Han S, Peng H, et al · · 2023 · cited 6× · PMID 36819512 · DOI 10.21037/atm-22-6485

Verify or expand the search:

Other recruiting trials for Healthy Volunteers

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Other Qilu Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

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NCT07463573 — QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma · Phase 3 · not yet recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05528198 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Qilu Pharmaceutical Co., Ltd.
Last refreshed: 11 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05528198.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing