Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions
| Status: | Completed |
|---|---|
| Conditions: | Asthma, Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | August 2008 |
| End Date: | August 2008 |
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet
under fasted conditions.
under fasted conditions.
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.
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