Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test 1 Montelukast · 1 trial · 1 indication
Plasma PK parameters includes Maximum observed concentration (Cmax), Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite\[inf\] time (AUC\[0-inf\]) and Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC\[0-t\]).
| Arm | Type | Description |
|---|---|---|
| Sequence ABC | EXPERIMENTAL | Subjects will be administered a single oral dose of treatment A, B and C in the sequence ABC, where A is Reference Treatment: 5 mg montelukast sodium reference chewable tablets (innovator product); B is Test Formulation 1: 5mg montelukast sodium (GW483100) chewable tablet and C is Test Formulation 2: 5mg montelukast sodium (GW483100) chewable tablet. The treatment periods will be separated by a washout period of 7 to 14 days |
| Sequence ACB | EXPERIMENTAL | Subjects will be administered a single oral dose of treatment A, B and C in the sequence ACB, where A is Reference Treatment: 5 mg montelukast sodium reference chewable tablets (innovator product); B is Test Formulation 1: 5mg montelukast sodium (GW483100) chewable tablet and C is Test Formulation 2: 5mg montelukast sodium (GW483100) chewable tablet. The treatment periods will be separated by a washout period of 7 to 14 days |
| Sequence BAC | EXPERIMENTAL | Subjects will be administered a single oral dose of treatment A, B and C in the sequence BAC, where A is Reference Treatment: 5 mg montelukast sodium reference chewable tablets (innovator product); B is Test Formulation 1: 5mg montelukast sodium (GW483100) chewable tablet and C is Test Formulation 2: 5mg montelukast sodium (GW483100) chewable tablet. The treatment periods will be separated by a washout period of 7 to 14 days |
| Sequence BCA | EXPERIMENTAL | Subjects will be administered a single oral dose of treatment A, B and C in the sequence BCA, where A is Reference Treatment: 5 mg montelukast sodium reference chewable tablets (innovator product); B is Test Formulation 1: 5mg montelukast sodium (GW483100) chewable tablet and C is Test Formulation 2: 5mg montelukast sodium (GW483100) chewable tablet. The treatment periods will be separated by a washout period of 7 to 14 days |
| Sequence CAB | EXPERIMENTAL | Subjects will be administered a single oral dose of treatment A, B and C in the sequence CAB, where A is Reference Treatment: 5 mg montelukast sodium reference chewable tablets (innovator product); B is Test Formulation 1: 5mg montelukast sodium (GW483100) chewable tablet and C is Test Formulation 2: 5mg montelukast sodium (GW483100) chewable tablet. The treatment periods will be separated by a washout period of 7 to 14 days |
| Sequence CBA | EXPERIMENTAL | Subjects will be administered a single oral dose of treatment A, B and C in the sequence CBA, where A is Reference Treatment: 5 mg montelukast sodium reference chewable tablets (innovator product); B is Test Formulation 1: 5mg montelukast sodium (GW483100) chewable tablet and C is Test Formulation 2: 5mg montelukast sodium (GW483100) chewable tablet. The treatment periods will be separated by a washout period of 7 to 14 days |
| Name | Type | Description |
|---|---|---|
| Reference Montelukast | DRUG | It is available as pink, round, bi-convex-shaped chewable tablet of reference 5 mg montelukast sodium (innovator product). that has to be placed on the tongue and chewed immediately. |
| Test 1 Montelukast | DRUG | It will be provided as pink, round, bi-convex-shaped chewable tablet of test formulation 1: 5mg montelukast sodium (GW483100) that has to be placed on the tongue and chewed immediately. |
| Test 2 Montelukast | DRUG | It will be provided as pink, round, bi-convex-shaped chewable tablet of test formulation 2: 5mg montelukast sodium (GW483100) that has to be placed on the tongue and chewed immediately. |
Inclusion Criteria: * Male and females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory te...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Ralinepag |
| AstraZeneca PLC | AZN | 2 | - | Undisclosed |
| Intuitive Surgical, Inc. | ISRG | 1 | - | Undisclosed |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | - | Undisclosed |
Montelukast is a small molecule being developed for respiratory disorders. It is currently in Phase 1 clinical development as an investigational drug. The drug is being studied for its potential use in treating conditions related to the respiratory system.
Montelukast is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company is conducting clinical research on this drug for respiratory disorders.
Montelukast is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The drug is being studied for respiratory disorders, and its safety and bioavailability are being evaluated in early-stage trials.
Montelukast has one completed clinical trial registered as NCT02322671. This Phase 1 study evaluated the relative bioavailability of two montelukast sodium 5 mg chewable tablets compared to a reference tablet in healthy adult subjects. The trial enrolled 18 participants and was conducted in India.
Montelukast is also known as GW483100. The clinical trial NCT02322671 refers to montelukast sodium as GW483100, confirming that these names refer to the same drug substance being developed by GSK plc.