Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions

Roxane Laboratories

Status and phase: Completed; Early Phase 1

Conditions: Asthma

Treatments: Drug: Montelukast; Drug: Singulair

Study type: Interventional

Funder types: Industry

Identifiers

NCT01659918

MONT-T10-PVFD-1

Details and patient eligibility

About

The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed conditions

Enrollment: 35 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

35 participants in 2 patient groups

Montelukast

Active Comparator group

Description:

10 mg Tablet

Treatment:

Drug: Montelukast

Singulair

Active Comparator group

Description:

10 mg Tablet

Treatment:

Drug: Singulair