Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cefdinir · 4 trials · 1 indication
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Cefdinir Capsules 300 mg | DRUG | 1 x 300 mg, single-dose non-fasting |
| OMNICEF® Capsule 300 mg | DRUG | 1 x 300 mg, single-dose non-fasting |
| OMNICEF® 300 mg | DRUG | 1 x 300 mg, single-dose fasting |
| Cefdinir for oral suspension 250 mg/5mL | DRUG | 1 x 250 mg/5mL, single-dose non-fasting |
| OMNICEF® for oral suspension 250 mg/5mL | DRUG | 1 x 250 mg/5mL, single-dose non-fasting |
Inclusion Criteria: * Screening Demographics: All subjects selected for this study will be healthy men and women 18 years of age or older at the time of dosing. the subject's body mass index (BMI) should be 19 kg/m² - 30 kg/m², inclusive. * Screening procedures: Each subject will complete the scree...
Cefdinir is an investigational small molecule being studied in healthy volunteers. It is being developed by Teva Pharmaceutical Industries Limited (TEVA). The drug is currently in Phase 1 clinical development, with all completed trials conducted in the United States.
Cefdinir is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials of the drug in healthy volunteers in the United States.
Cefdinir is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All four clinical trials for Cefdinir have been completed, with a total enrollment of 128 participants.
Cefdinir has been studied in four completed Phase 1 clinical trials: NCT00834535 (Cefdinir Capsules 300 mg, Non-fasting), NCT00834574 (Cefdinir for Oral Suspension 250 mg/5mL, Fasting), NCT00835484 (Cefdinir Capsules 300 mg, Fasting), and NCT00835549 (Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting). Each trial enrolled 32 healthy volunteers.
Yes, the clinical trials for Cefdinir are randomized and active-controlled. They are not double-blind and do not use biomarker selection. The trials enrolled healthy volunteers aged 18 years and older, with both males and females included.