Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Clarithromycin · 1 trial · 1 indication
Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUC0-t)
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-∞)
Maximum observed plasma concentration (Cmax)
Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity
Cmax
| Arm | Type | Description |
|---|---|---|
| Midazolam cohort | EXPERIMENTAL | Midazolam Oral Solution will be given orally once daily within 0.5 hours after breakfast on Day 1 and Day 10. TNP-2198 Capsules will be given orally twice daily within 0.5 hours after breakfast and dinner from Day 3 to Day 11. |
| Clarithromycin cohort | EXPERIMENTAL | Clarithromycin tablets will be given orally within 0.5 hours after breakfast and dinner from Day 16 to Day 25. TNP-2198 Capsules will be given orally twice daily within 0.5 hours after breakfast and dinner from Day 1 to Day 7 and from Day16 to Day 22, and once daily within 0.5 hours after breakfast on Day 8 and Day 23. |
| Name | Type | Description |
|---|---|---|
| Midazolam | DRUG | Midazolam Oral Solution 2 mg |
| Clarithromycin | DRUG | Clarithromycin tablets 0.5 g |
| TNP-2198 | DRUG | TNP-2198 Capsules 400 mg |
Inclusion Criteria: * Be able to provide written Informed consent forms (ICF) and fully understand the study procedures and potential AEs. * Be able to comply with all protocol requirements. * Willing to voluntarily take effective contraceptive measures from signing the ICF to 3 months after the la...
Clarithromycin is a small molecule antibiotic being studied for use in Helicobacter pylori infection. It is currently in Phase 1 clinical development as part of a drug-drug interaction study. The drug is being developed by cbdMD, Inc. for this infectious disease indication.
Clarithromycin is a macrolide antibiotic that works by inhibiting bacterial protein synthesis. It binds to the 50S ribosomal subunit of susceptible bacteria, blocking peptide bond formation and preventing bacterial growth. This mechanism makes it effective against Helicobacter pylori and other susceptible organisms.
Clarithromycin is being developed by cbdMD, Inc., a company traded under the ticker symbol YCBD. The company is conducting clinical research on this antibiotic for the treatment of Helicobacter pylori infection, with the drug currently in Phase 1 development.
Clarithromycin is in Phase 1 clinical development. It is an investigational drug being studied for Helicobacter pylori infection. The drug is not yet approved and remains in early-stage clinical trials, with one completed Phase 1 study evaluating drug-drug interactions.
Clarithromycin has one completed clinical trial registered as NCT06551623, titled "Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin." This Phase 1 study enrolled 32 participants in China, including healthy volunteers aged 18 years and older, and evaluated drug interactions in the context of Helicobacter pylori infection.
Clarithromycin is not the same as TNP-2198. The clinical trial NCT06551623 evaluates drug-drug interactions between TNP-2198 and Clarithromycin, indicating they are distinct compounds. Clarithromycin is the antibiotic being studied, while TNP-2198 is a separate investigational drug in the same trial.