Trials / Completed
CompletedNCT05531994
Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fed Healthy Volunteers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 fed condition.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-11-27
- Primary completion
- 2019-05-14
- Completion
- 2019-05-14
- First posted
- 2022-09-08
- Last updated
- 2023-05-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05531994. Inclusion in this directory is not an endorsement.