Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03898193 | Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions | PHASE1 | COMPLETED | 34 | — | — | Mar 23, 2019 | Apr 8, 2019 | Jun 6, 2019 | 1 | Russia |
Maximum concentration in plasma among observed concentrations at pre-specified time points
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
| Arm | Type | Description |
|---|---|---|
| Sequence Test-Reference (TR) | OTHER | 17 participants (total number of enrolled volunteers - 34) assigned to sequence TR will receive a single 5 mg dose of the test product Montelukast (1 x 5 mg tablet) marked as T in period 1 and a single 5 mg dose of the reference product Singulair (1 x 5 mg tablet) marked as R in period 2. These treatments will be administered orally with 200 ml of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence Reference-Test (RT) | OTHER | 17 participants (total number of enrolled volunteers - 34) assigned to sequence RT will receive a single 5 mg dose of the reference product Singulair (1 x 5 mg tablet) marked as R in period 1 and a single 5 mg dose of the test product Montelukast (1 x 5 mg tablet) marked as T in period 2. These treatments will be administered orally with 200 ml of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Name | Type | Description |
|---|---|---|
| Montelukast | DRUG | Montelukast, 5 mg Chewable Tablets, manufactured by Pharmtechnology LLC, Republic of Belarus |
| Singulair | DRUG | Singulair, 5 mg Chewable Tablets, marketed by Merck Sharp \& Dohme B.V., the Netherlands |
Inclusion Criteria: * Healthy caucasian men or women aged between 18 to 45 years * Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments and imaging studies * Body mass index 18.5-30 kg/m² with b...