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MARLYNNE MICALIZZI, M.S., is Associate Director, Early Development and Clinical Pharmacology, Wyeth Research, Collegeville, PA. POLLY FRAGA, M.D., was Director, Clinical Research and Development, Wyeth Research, at the time of this study. XU MENG, PH.D., is Senior Director, Early Development and Clinical Pharmacology, Wyeth Research.

Address correspondence to Ms. Micalizzi at Clinical Research, Wyeth Research, Collegeville, PA 19426 (micalim{at}wyeth.com).

Purpose. The safety and tolerability of 80 mg i.v. pantoprazole administered as a 2-minute versus a 15-minute infusion were studied. Methods. In a single-blind, randomized, multiple-dose, parallel-group study, 48 healthy participants (ages 18–45 years) were randomly assigned for treatment with 80 mg i.v. pantoprazole infused for 2 or 15 minutes once daily for seven days. A blinded evaluator assessed the injection site for phlebitis and infiltration on a 5-point scale at specified intervals. Participants completed the visual analogue scale (VAS) for pain and burning at baseline and at 5 minutes postinjection. Results. More than 99% of the preinfusion and postinfusion infiltration scores and >95% of the phlebitis scores were rated as zero in 48 healthy participants. A total of 7 infiltration scores (1%) and 72 postinfusion phlebitis scores (5%) of greater than 0 were recorded, all of which were mild in nature. Forty-one phlebitis scores of 1 and 1 score of 2 were from 12 participants in the 2-minute group, and 20 scores of 1 and 10 scores of 2 were from 8 participants in the 15-minute group. VAS assessments showed that the perception of pain and burning was not greater in the 2-minute group. There were no significant differences in adverse events between the two groups. Conclusion. The safety and tolerability profiles of i.v. pantoprazole administered as a 2-minute infusion were similar to those of the 15-minute infusion. This protocol may result in the savings of staff time with no additional discomfort to the patient. Index terms: Drug administration rate; Gastrointestinal drugs; Injections; Pantoprazole; Toxicity