EBV Clinical Trial
Official title:
Research About the Differences Between Chidamide Taken Daily and Twice a Week in Pharmacokinetics
1. To compare the therapeutic effects, safety and the corresponding pharmacokinetics and
pharmacodynamics between two different method of drug administration: 10mg, daily and
30mg/d, twice every week, and find out the more effect way of Chidamide administration.
2. To examine whether Chidamide could activate EB virus, and whether the above two
different ways of administration are different in EB virus activation.
Currently, Chidamide is taken twice a week, this comes from cell experiment and phase I
clinical trial, which showed that the de-acetylation effect of Chidamide could last for 72
hours after administration. However, daily administration of Chidamide may create a more
steady Chidamide concentration, thus improve the de-acetylation effect of Chidamide, so it's
necessary to compare the two different ways of administration.
Current study showed that Romidepsin, a HDACI, could activate EBV during the treatment of
NKTCL, whether Chidamide, as a novel HDACI, could activate EBV is still not clear, so this
problem is worth to be accessed.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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