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Montelukast chewable · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Montelukast sodium | EXPERIMENTAL | Montelukast sodium chewable tablets 4mg and 5mg of Dr. Reddy's Laboratories Limited |
| SINGULAIR® | ACTIVE_COMPARATOR | SINGULAIR®(containing Montelukast sodium) chewable tablets 4mg and 5mg of Merck Sharp \& Dohme Ltd., USA |
| SINGTJLAIR ® | ACTIVE_COMPARATOR | SINGTJLAIR ® (containing Montelukast sodium)chewable tablets 5mg of Merck Sharp \& Dohme Ltd., USA |
| Name | Type | Description |
|---|---|---|
| Montelukast sodium chewable tablets 4mg and 5mg | DRUG | Montelukast sodium chewable tablets 4mg and 5mg |
| Montelukast sodium chewable tablets 4 mg and 5 mg | DRUG | Montelukast sodium chewable tablets 4mg and 5mg |
Inclusion Criteria: Subjects were selected based on the following inclusion criteria: * Provide written informed consent. * Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg. * Having a body mass index between 18.0 and 24.9 (both inclusive)...
Montelukast sodium chewable tablets 4 mg and 5 mg are a chewable oral formulation of montelukast, a small molecule drug developed by Dr. Reddy's Laboratories Ltd. The product is studied in bioequivalence trials in healthy adult male volunteers. The specific therapeutic indication for this chewable tablet program is undisclosed.
Montelukast targets CYSLTR1, the cysteinyl leukotriene receptor 1. It acts as an antagonist at this receptor, blocking cysteinyl leukotriene signaling. This mechanism underlies the drug's activity as a small molecule leukotriene receptor antagonist.
Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY, is the developer of these montelukast sodium chewable tablets in 4 mg and 5 mg strengths. The company conducted the bioequivalence studies supporting this chewable tablet program.
The program is in Phase 1. Two Phase 1 bioequivalence trials have been completed, and no trials are currently active. The studies enrolled a total of 98 healthy adult male volunteers in India. The development stage reflected by these trials is early clinical testing.
Two completed Phase 1 bioequivalence trials are registered: NCT01674517, conducted under fed conditions with 35 healthy male volunteers, and NCT01674504, conducted under fasting conditions with 63 healthy male volunteers. Both were active-controlled, randomized studies run in India in adults aged 18 years and older.