Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Cefprozil
Cefprozil · 3 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 |
|---|---|---|
| Cefprozil for oral suspension 250 mg/5 mL | DRUG | 1 x 250 mg/5 mL, single-dose fasting |
| CEFZIL® for Oral Suspension 250 mg/5mL | DRUG | 1 x 250 mg/5 mL, single-dose fasting |
| cefprozil | DRUG | 500 mg Tablet |
| Cefzil® | DRUG | 500 mg Tablet |
Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less. * Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but i...
Cefprozil is an antibiotic that Teva Pharmaceutical Industries Limited has studied in Phase 1 clinical trials. The trials listed for this asset enrolled healthy adult volunteers in the United States, so the studied use in these trials was healthy volunteer pharmacokinetic assessment rather than a specific patient population.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of Cefprozil. The company sponsored the Phase 1 trials of the 500 mg tablet and the 250 mg/5 mL oral suspension formulations that appear in the clinical record.
Cefprozil is in Phase 1 development for this program. All three listed trials are Phase 1 studies, and all three are completed, with no active trials currently listed. Total enrollment across the three studies was 91 participants.
Three completed Phase 1 trials are listed: NCT00840866 tested Cefprozil 500 mg tablets under fed conditions with 39 participants, while NCT00835614 and NCT00835354 each tested the 250 mg/5 mL oral suspension with 26 participants, one fasting and one non-fasting. All enrolled healthy adults in the United States.
The three Phase 1 trials were randomized and active controlled, and none were double blinded. They enrolled healthy volunteers aged 18 years and older of any sex, and compared the 500 mg tablet or the 250 mg/5 mL oral suspension under fed, fasting, and non-fasting conditions.