Bioequivalence and Bioavailability Forum • Montelukast BE study

Montelukast BE study - Cmax shows supra bioavailability [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2016-12-01 14:56 (3033 d 05:38 ago) – Posting: # 16820
Views: 10,013

Hi
Montelukast is rapidly absorbed following oral administration. For the 10 mg film-coated tablet the mean oral bioavailability is 64%. For the 5 mg chewable tablet, the mean oral bioavailability is 73% and is decreased to 63% by a standard meal.

So, no BCS class I substance (BA < 85%). But even if it would be a BCS class I substance you have the results of the BE study and you can not ignore this.

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

Montelukast BE study - Cmax shows supra bioavailability elam 2016-12-01 08:20 [Regulatives / Guidelines]
- Montelukast BE study - Cmax shows supra bioavailability nobody 2016-12-01 10:03
  - Montelukast BE study - Cmax shows supra bioavailabilityDr_Dan 2016-12-01 13:56
  - Montelukast BE study - Cmax shows supra bioavailability elam 2016-12-04 08:32
- Montelukast BE study - Cmax shows supra bioavailability ElMaestro 2016-12-01 14:50
  - Montelukast BE study - Cmax shows supra bioavailability nobody 2016-12-01 15:34
- Montelukast BE study - Cmax shows supra bioavailability elam 2016-12-04 08:59