We conclude that BR-DIM is well tolerated at single doses of up to 200 mg, and that increasing the dose to 300 mg did not result in an increase in Cmax.Ĭruciferous vegetables such as cabbage, broccoli, cauliflower and brussel sprouts contain several chemicals which have been shown to modulate carcinogenesis in animals ( 1- 10) and humans ( 11, 12). The single 300 mg dose of BR-DIM resulted in a mean Cmax of 108 ng/ml and a mean AUC of 532 hr*ng/ml. The single 100 mg dose of BR-DIM resulted in a mean Cmax of 32 ng/ml, and a mean AUC of 128 hr*ng/ml, and a single 200 mg dose produced a mean Cmax of 104 ng/ml and a mean AUC of 553 hr*ng/ml. Analysis of serial plasma samples showed that only one subject at the 50 mg dose had detectable concentrations of DIM. Only the latter effect was judged as probably related to study agent. At the 300 mg dose, one of six subjects reported mild nausea and headache and one also reported vomiting. No BR-DIM-related adverse effects were reported at doses up to 200 mg. Doses administered were 50, 100, 150, 200, and 300 mg, with the 300 mg dose repeated in an additional group. After randomization, one subject in each group received placebo while three received active BR-DIM. Groups of four subjects were enrolled for each dose level. We determined the safety, tolerability, and pharmacokinetics of single doses of BR-DIM in drug-free, non-smoking, healthy men and women. The study agent was nutritional-grade, absorption-enhanced BioResponse® 3, 3′-diindolylmethane (BR-DIM). We have completed a single ascending dose clinical study of the proposed chemopreventive agent 3, 3′-dindolylmethane (DIM).
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