Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fasted Conditions

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01659905

Enrollment

Registered

2012-08-08

Start date

2008-08-31

Completion date

2008-08-31

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fasted conditions.

Interventions

DRUGMontelukast

Chewable Tablet

DRUGSingulair

5 mg Chewable Tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion criteria

* Positive test for HIV, Hepatitis B, or Hepatitis C. * Treatment with known enzyme altering drugs. * History of allergic or adverse response to montelukast or any comparable or similar product.

Design outcomes

Primary

Measure	Time frame
bioequivalence determined by statistical comparison Cmax	9 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026