Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Naprelan · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Naproxen Sodium, (BAY H6689) | DRUG | One dose of Naproxen sodium extended release 660 mg under fasting conditions |
| Naprelan, (BAY H6689) | DRUG | One dose of Naprelan 500 mg (2 tablets) under fasting conditions |
Inclusion Criteria: * Healthy male and female subjects between 18 to 55 years of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs) * Results of screening and clinical laboratory tests are within normal range or considered not clini...
Naprelan is a small molecule drug being studied for pharmacokinetics, which is the study of how the drug is absorbed, distributed, metabolized, and eliminated in the body. It is currently in Phase 1 clinical development for this indication.
Naprelan does not have a specified molecular target or target class. It is a small molecule drug being investigated for pharmacokinetics, meaning the focus of its clinical study is on how the body processes the drug rather than on a specific biological target.
Naprelan is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY.
Naprelan is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently ongoing. The drug is investigational and has not been approved for any use.
Naprelan has one completed clinical trial, identified by the NCT number NCT00969449. This was a Phase 1 study titled 'Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan,' which enrolled 28 participants in the United States.
Naprelan is being studied in comparison to naproxen sodium extended release in a clinical trial. The trial NCT00969449 was designed to compare the pharmacokinetics of the two formulations, but it is not stated that they are the same drug.