Bioequivalence Of Two Formulations Of Monteluka...

Trauma In Elderly People Attended By A Mobile E...

Downregulation Of Il-8, Ecp, And Total Ige In T...

0 votes
Bioequivalence Of Two Formulations Of Montelukast Sodium 4 Mg Oral Granules In Healthy Adults
Author: Constanze Fey, Ursula Thyroff-friesinger And Spencer Jones
Publisher: Derivative Works
5 pages
One time payment: €0.00
Required subscription: Free
Type of publication: Article
ISBN/ISSN: 2045-7022
DOI: 10.1186/2045-7022-4-29
Follow this publisher

Share this publication:


Montelukast is an effective and well-tolerated treatment for the prophylaxis and chronic treatment of asthma, acute prevention of exercise-induced bronchoconstriction and symptomatic relief of seasonal allergic rhinitis and perennial allergic rhinitis. The aim of the study was to compare bioavailability, and characterise the pharmacokinetic profile and safety of Sandoz generic montelukast 4 mg oral granules relative to Singulair® mini (Merck, Sharp & Dohme). An open-label, randomised, single-dose, two-treatment, two-period, two-sequence, two-way crossover bioequivalence study was conducted in healthy male volunteers aged 18–55 years, under fasting conditions. The duration of the clinical part of the trial was ≈ 11 days. Montelukast levels in plasma were quantified using a validated liquid chromatography tandem mass spectrometry method, and pharmacokinetic parameters calculated from the drug concentration–time profile using a non-compartmental model. A total of 40 subjects completed both study periods. The ratio test/reference of geometric least squares means was calculated for both formulations of montelukast for the In-transformed pharmacokinetic parameters; the 90% confidence intervals (CIs) were within the pre-defined limits of 80.00–125.00%: 92.2% (90% CI: 87.42–97.30%) for Cmax, 98.1% (90% CI: 94.49–101.81%) for AUC0–t and 97.6% (90% CI: 94.14–101.27%) for AUC0–∞. Two study subjects each reported one mild adverse event: dyspepsia (possibly related to study medication) and throat pain (not considered related to study medication). Sandoz montelukast 4 mg oral granules are bioequivalent to Singulair® 4 mg mini oral granules, with a similar safety profile. This suggests that these two preparations can be considered interchangeable in clinical practice.

About the publisher:

We are a publishing house devoted to reuse CC-BY licensed published materials.


Using CC-BY licenses:


  • Adapt — remix, transform, and build upon the material
  • for any purpose, even commercially.
  • The licensor cannot revoke these freedoms as long as you follow the license terms.


  • No additional restrictions — You may not apply legal terms or technological measures that legally restrict others
    from doing anything the license permits.


  • You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation.
  • No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material.

Select a payment method