The Pharmacokinetics of Orally Administered Calcium Pantothenate in Healthy Adults

Abstract

Pantothenic acid, aka Vitamin B5, is essential for production of coenzyme-A, an important component of energy metabolism. The pharmacokinetics (PK) of orally administered calcium pantothenate are not well characterized. This single-center, open-label study of 40 adults investigated single and multidose PK of orally administered calcium pantothenate. Tolerability of high doses and impact of food were also evaluated. This study included Single Ascending Dose (SAD) and Multiple Dose (MD) periods. For the SAD, four sequential cohorts of 8 subjects received single doses of calcium pantothenate after an overnight fast. Doses were 500 mg, 1000 mg, 2000 mg and 5000 mg; with the 5000 mg dose repeated following a 2-week washout and after a highfat meal. In the MD period, 8 subjects received 2000 mg daily for 14 days. PK samples were collected for 192 hours post-last dose in the SAD and MD periods, with frequent sampling on Days 1 and 14, and pre-dose samples on Days 12 and 13 in the MD group. Absorption was rapid with peak concentrations reached approximately 1-hour post-dose under fasted conditions. Exposure (AUC) increased with dose from 500 to 2000 mg with no further increase between 2000 and 5000 mg. Terminal half-life averaged 225 hours. Peak exposure (Cmax) increased greater than dose-proportionally from 500 to 2000 mg. Food delayed absorption by 2 hours (1.002 versus 2.995 hours), and increased AUC by 55%. Steady state was achieved by Day 14 with a 3.1-fold accumulation for AUC0-24. No deaths, serious adverse events, or discontinuations for adverse events occurred.