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Chapter 6 130 0 60 120 180 240 300 360 420 480 540 600 720 840 1440 0 200 400 600 800 1000 Time (min) Plasma menthol-glucuronide (µg/L) Small-intestinal release peppermint oil, N=8 Ileocolonic release peppermint oil, N=8 ( P =0.010). Median difference in T max between both formulations in individual participants was 180 minutes, (IQR 180-240, 95% CI 180-140). T lag was significantly delayed in ileocolonic release peppermint oil, with a median (IQR) of 225 (204-284) versus 37 (6- 65) minutes, P <0,05 ( P =0.012). In addition, AUCs 0-24hrs differed significantly between the ileocolonic and the small-intestinal release capsules, with a median (IQR) of 2331 μg*h/L (2006-2510) and 2623 μg*h/L (2471-2920) respectively, P <0.05 ( P =0.017). No significant differences were found in C max ( P =0.28) and T 1/2 ( P =0.16) of either capsule. Mean ratios of log-transformed AUCs and C max of 1.02 (90% CI 1.01-1.04) were found. Figure 6.2 Concentration-time curve, menthol-glucuronide concentration was measured in 8 healthy volunteers ( N =8) in ug/mL on 14 time points after both peppermint oil (PO) capsule administrations. The ileocolonic release PO has a significantly elongated time to reach the maximum plasma concentration. Circles and squares represent median plasma glucuronide levels + Interquartile Range (+IQR). Adverse events and tolerability No serious adverse events occurred during the study nor during one week follow up. Adverse events were reported in five subjects, but were all mild and transient. Adverse events are shown in Table 6.5 .