Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Commercial Aleve · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Naproxen Sodium 660mg | DRUG | Extended release Naproxen Sodium (660mg) administered once a day |
| Commercial Aleve 220 mg | DRUG | Immediate release commercial Aleve (220 mg) administered in a 2 (440 mg) plus one (220 mg) dosing schedule, 660 mg total |
Inclusion Criteria: * Healthy, ambulatory, male and female volunteers between 18 - 55 years of age with BMI of approximately 18 to 30 kg/m2, and total body weight \>50 kg (110Ibs) Exclusion Criteria: * History of hypersensitive to aspirin (ASA), naproxen sodium, or acetaminophen, and similar phar...
Commercial Aleve is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial involving 32 participants in the United States. The drug is being investigated for its bioavailability and is not yet approved for any medical condition.
Commercial Aleve is developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The company is conducting clinical research on this drug, which is currently in Phase 1 development.
Commercial Aleve is in Phase 1 clinical development. It has completed one Phase 1 trial, NCT00751556, which was a single and multiple dose bioavailability study. The drug is investigational and has not been approved by regulatory authorities.
Commercial Aleve has one completed clinical trial, NCT00751556, titled 'Single/Multiple Dose Bioavailability Trial'. This Phase 1 study enrolled 32 healthy volunteers in the United States, with participants aged 18 years and older. The trial was active-controlled and randomized.
Commercial Aleve is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only trial associated with it, NCT00751556, has been completed, but the drug has not progressed to later stages or received regulatory approval.