Kees, Frieder and Mair, G. and Dittmar, M. and Bucher, M. (2004) Cicloral versus neoral: A bioequivalence study in healthy volunteers on the influence of a fat-rich meal on the bioavailability of Cicloral. TRANSPLANTATION PROCEEDINGS, 36 (10). pp. 3234-3238. ISSN 0041-1345,
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The bioavailability of cyclosporine a (CyA) was assessed in 2 cross-over studies with 12 healthy male volunteers each. Study A compared the bioavailability of Cicloral (test) with the microemulsion Neoral (reference) in the fasting state. Study B examined the influence of a fat-rich meal composed according to the Food and Drug Administration (FDA) recommendations on the bioavailability of Cicloral. Each volunteer received a single dose of 200 mg CyA in each period. Whole blood CyA concentrations were determined using HPLC up to 48 hours after drug administration. The pharmacokinetic parameters were determined using standard noncompartmental methods. The mean bioavailability of Cicloral compared with Neoral amounted to 83% (AUC) and 78% (Cmax), respectively. When administered after a fat-rich meal, the bioavailability of Cicloral was 121% (AUC) and 132% (Cmax) compared with fasting administration. Time to Cmax was 1.3 to 1.4 hours for both medications and modes of administration. Bioequivalence could not be proven either between Cicloral and Neoral, or between Cicloral fasting versus after a fat-rich meal. We conclude that the lower bioavailability and the influence of food on the bioavailability of Cicloral must be taken into account when switching from Neoral to the generic formulation.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CYCLOSPORINE-A; CLINICAL PHARMACOKINETICS; AUTOIMMUNE-DISEASE; CYTOTOXIC AGENTS; FORMULATION; TOXICITY; FOOD; DRUG; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine 600 Technology > 615 Pharmacy |
| Divisions: | Medicine > Lehrstuhl für Anästhesiologie Chemistry and Pharmacy > Institute of Pharmacy > Alumni or Retired Professors > Prof. Frieder Kees |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 21 Jun 2021 13:09 |
| Last Modified: | 21 Jun 2021 13:09 |
| URI: | https://pred.uni-regensburg.de/id/eprint/36938 |
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