The rate of absorption and relative bioavailability of caffeine administered in chewing gum versus capsules to normal healthy volunteers

Objective:The purpose of this study was to evaluate the rate of absorption and relative bioavailability of caffeine from a Stay Alert® chewing gum and capsule formulation. Methods: This was a double blind, parallel, randomized, seven treatment study. The treatment groups were: 50, 100, and 200 mg gum, 50, 100, and 200 mg capsule, and a placebo. Subjects consisted of 84 ( n=12 per group); healthy, non-smoking, males who had abstained from caffeine ingestion for at least 20 h prior to dosing and were randomly assigned to the treatment groups. Blood samples were collected pre-dose and at 5, 15, 25, 35, 45, 55, 65, 90 min and 2, 3, 4, 6, 8, 12, 16 and 29 h post administration. Plasma caffeine levels were analyzed by a validated UV-HPLC method. Results: Mean T max for the gum groups ranged from 44.2 to 80.4 min as compared with 84.0–120.0 min for the capsule groups. The T max, for the pooled data was significantly lower ( P