Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Singulair · 1 trial · 1 indication
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...
Singulair is a small molecule drug being studied in healthy adults. In the completed Phase 1 clinical trial, it was evaluated as a 5 mg chewable tablet for bioequivalence purposes. The study involved healthy volunteers under fasting conditions to compare the pharmacokinetics of the test product against the reference product.
Singulair is being developed by Ligand Pharmaceuticals Incorporated, which trades under the ticker LGND. The drug is a small molecule modality. In the clinical trial, the reference product was manufactured by Merck Sharp & Dohme B.V., the Netherlands, while the test product was from Pharmtechnology LLC, Belarus.
Singulair is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug is not currently in active clinical trials.
Singulair has one completed clinical trial, NCT03898193. This was a Phase 1 bioequivalence study of montelukast 5 mg chewable tablets compared to Singulair 5 mg chewable tablets in healthy volunteers under fasting conditions. The trial enrolled 34 participants in Russia and was a controlled, randomized study.
Singulair is the brand name for montelukast. In the clinical trial NCT03898193, the study compared montelukast 5 mg chewable tablets from Pharmtechnology LLC against Singulair 5 mg chewable tablets from Merck Sharp & Dohme B.V. The trial was designed to assess bioequivalence between the two formulations.
The clinical trial for Singulair, NCT03898193, was biomarker-selected. However, the specific biomarker targeted is not disclosed in the available information. The study was a bioequivalence trial in healthy adults, and no molecular target has been specified for this drug.