Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Montelukast chewable · 1 trial · 1 indication
Pharmacokinetics
Pharmacokinetics
| Arm | Type | Description |
|---|---|---|
| A(reference)/B(test) | EXPERIMENTAL | initial administration of reference and cross-over to test |
| B(test)/A(reference) | EXPERIMENTAL | initial administration of test and cross-over to reference |
| Name | Type | Description |
|---|---|---|
| Montelukast 5 mg chewable tablets | DRUG | Reference product |
Inclusion Criteria: Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice. Healthy, between 18 and 50 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; he...