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 a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is available in formulations including Cefdinir Capsules 300 mg and Cefdinir for oral suspension 250 mg/5mL. The clinical program recorded for Cefdinir consists of Phase 1 trials conducted in healthy adult volunteers in the United States.
Cefdinir is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The registered clinical trials for Cefdinir were sponsored under this developer, covering both the 300 mg capsule and the 250 mg/5mL oral suspension formulations evaluated in healthy volunteers in the United States.
Cefdinir is in Phase 1 clinical development. Four Phase 1 trials have been registered, and all four are completed, with no active trials currently listed. Total enrollment across these studies was 128 participants. The trials were randomized and active controlled, and they enrolled healthy adult volunteers.
Four completed Phase 1 trials of Cefdinir are registered: NCT00835549 tested the oral suspension 250 mg/5mL under non-fasting conditions, NCT00835484 tested capsules 300 mg under fasting conditions, NCT00834574 tested the oral suspension 250 mg/5mL under fasting conditions, and NCT00834535 tested capsules 300 mg under non-fasting conditions.
Cefdinir trials enrolled a total of 128 participants across four completed Phase 1 studies. Each of the four trials enrolled 32 healthy adult volunteers aged 18 years and older, with both sexes eligible. The studies were randomized and active controlled, and all were conducted in the United States.