Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Clarithromycin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Clarithromycin 250 mg Tablets (Geneva, USA) |
| 2 | ACTIVE_COMPARATOR | Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA) |
| Name | Type | Description |
|---|---|---|
| Clarithromycin 250 mg Tablets (Geneva, USA) | DRUG | - |
| Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA) | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.
Clarithromycin is a small molecule antibiotic being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating the relative bioavailability of 250 mg tablets under fasting conditions.
Clarithromycin is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical research on this small molecule antibiotic.
Clarithromycin is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational, meaning it is still being studied and is not yet approved for any use.
Clarithromycin has one completed clinical trial, NCT00881738, which was a Phase 1 study titled "To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions." The trial enrolled 32 healthy participants.
Clarithromycin is not FDA approved based on the available clinical data. It is an investigational drug currently in Phase 1 development, with one completed trial in healthy volunteers. Approval status beyond this is not established.