Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 and 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 combination pairs an analgesic and anti-inflammatory agent with a nasal decongestant in a single oral dosage form.
Naproxen and pseudoephedrine targets PTGS2 and PTGS1, the cyclooxygenase enzymes, as an inhibitor. Naproxen sodium inhibits these prostaglandin-producing enzymes, while pseudoephedrine HCl acts as a decongestant component of the combination. The product is a small molecule formulation developed as an extended-release tablet.
Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY, is developing naproxen and pseudoephedrine. The company conducted the bioequivalence studies of its naproxen sodium 220 mg and pseudoephedrine HCl 120 mg extended-release tablets in India.
Naproxen and pseudoephedrine is in Phase 1 development. Two Phase 1 bioequivalence trials have been completed, and no trials are currently active. The studies enrolled healthy adult volunteers and were conducted under both fed and fasting conditions.
Two completed Phase 1 bioequivalence trials are registered for naproxen and pseudoephedrine: NCT01131767, conducted under fed conditions, and NCT01131728, conducted under fasting conditions. Each trial enrolled 26 healthy volunteers in India, for a total enrollment of 52 participants. Both were randomized and active controlled.