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

> **NCT05528198** · NA · COMPLETED · sponsor: **Qilu Pharmaceutical Co., Ltd.** · enrollment: 30 (actual)

## Conditions studied

- Healthy Volunteers

## Interventions

- **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)

## Key facts

- **NCT ID:** NCT05528198
- **Lead sponsor:** Qilu Pharmaceutical Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-12-28
- **Primary completion:** 2019-05-14
- **Final completion:** 2019-05-14
- **Target enrollment:** 30 (ACTUAL)
- **Last updated:** 2023-05-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05528198

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05528198, "Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fasted Healthy Volunteers". Retrieved via AI Analytics 2026-06-16 from https://api.ai-analytics.org/clinical/NCT05528198. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*