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PHARMACOKINETICS

Pharmacokinetics, Safety, and Tolerability of Doripenem After 0.5-, 1-, and 4-Hour Infusions in Healthy Volunteers

Iolanda Cirillo, MBS, Nicole Vaccaro, BS, Kenneth Turner, PhD, Bhavna Solanki, MS, Jaya Natarajan, PhD and Rebecca Redman, MD

From Johnson & Johnson Pharmaceutical Research & Development LLC, Raritan, New Jersey.

The pharmacokinetics, safety, and tolerability of doripenem in healthy subjects were evaluated in 2 studies. Study 1 was a double-blind, randomized, placebo-controlled dose-escalation study in which doripenem was administered for 7 days by infusion over 30 minutes (500 mg) or 1 hour (1000 mg). Study 2 was an open-label, randomized, 3-way crossover study in which each subject received a single dose of each of the following doripenem treatments on separate occasions: 500 mg infused over 1 hour, 500 mg infused over 4 hours, and 1000 mg infused over 4 hours. Doripenem exhibited linear pharmacokinetics with concordance between the studies for pharmacokinetic parameters. Doripenem did not accumulate with repeated dosing over 7 days. The area under the plasma concentration-time curve (AUC) for doripenem 500 mg infused over 1 hour versus 4 hours was bioequivalent, and the AUC and Cmax increased proportionally with dose for the 500- and 1000-mg doses administered over 4 hours. These results, along with the stability profile of doripenem, support its use as a prolonged infusion. All regimens of doripenem were safe and well tolerated.

Key Words: Doripenem • extended infusion • pharmacokinetics • safety

Address for reprints: Iolanda Cirillo, MBS, J&J Pharmaceutical Research & Development LLC, Route 202, Raritan, NJ 08869-3509.


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