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Naproxen & Pseudoephedrine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Naproxen Sodium & Pseudoephedrine HCl | EXPERIMENTAL | Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg ER Tablets of Dr. Reddy's Laboratories. |
| Aleve Cold and Sinus | ACTIVE_COMPARATOR | Aleve Cold and Sinus(Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets). |
| Name | Type | Description |
|---|---|---|
| Naproxen Sodium & Pseudoephedrine HCl | DRUG | Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets |
Inclusion Criteria: Subjects must fulfill all of the following criteria to be considered for inclusion into this study: * Subjects will provide written informed consent. * Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg. * Subjects must be within...
Naproxen & Pseudoephedrine is a fixed-dose combination product containing naproxen sodium 220 mg and pseudoephedrine HCl 120 mg in extended-release tablets. It is being developed by Dr. Reddy's Laboratories Ltd under ticker RDY. The product combines an analgesic and antipyretic agent with a nasal decongestant in a single oral dosage form.
Naproxen & Pseudoephedrine targets PTGS2 and PTGS1, the cyclooxygenase enzymes. The naproxen component acts as an inhibitor of these targets, while pseudoephedrine HCl provides decongestant activity as the second active ingredient in the combination. The product is a small molecule formulation.
Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY, is developing Naproxen & Pseudoephedrine. The company conducted the bioequivalence studies supporting this naproxen sodium and pseudoephedrine HCl extended-release tablet product.
Naproxen & Pseudoephedrine is in Phase 1 development. Two Phase 1 bioequivalence trials have been completed, and no trials are currently active. The program remains investigational and is not approved.
Two completed Phase 1 bioequivalence trials have evaluated Naproxen & Pseudoephedrine: NCT01131767, conducted under fed conditions, and NCT01131728, conducted under fasting conditions. Both enrolled 26 healthy adult volunteers in India, for a total enrollment of 52 participants across the program.