Functional Constipation Clinical Trial
Official title:
Effects of Oral Administration of a Chinese Proprietary Medicine, MZRW on Tolerability, Exposure and Pharmacokinetics in Healthy Subjects
This is a randomized open-label, three-arm, phase 1 clinical study. The investigators aim to investigate a Chinese Proprietary Medicine, MZRW on its tolerability, system exposure and pharmacokinetics profile.
This is a randomized, open-label, three-arm study. The participants will be enrolled and
randomized in a ratio of 1:1:1 to receive 5.0g, 7.5g, 10g b.i.d. of MZRW at 9 am
respectively. The study drug, MZRW will be administrated to the participants by site
personnel after participants have fasted overnight for more than 8 hours and 6 hours after
administration. Each participant will consume a standardized meal. In addition, the
participants refrain from Semen Cannabis Sativae, Semen Pruni Armeniacae, Radix Paeoniae,
Fructus Immaturus Citri Aurantii, Cortex Magnoliae and Radix et Rhizoma Rhei foods for 3
days before the study until completion of the study.
Blood samples (5 ml each) will be collected from the medial cubital vein into evacuated
tubes containing heparin just before and at 0.25, 0.5, 1, 2, 4, 8, 12h after administration
and were immediately centrifuged (1700g, 10 min). Plasma fractions were stored at -20°C
until analysis. All study procedures conduct in accordance with the ethical principles of
the Declaration of Helsinki, consistent with Good Clinical Practice guidelines, and approved
by Hong Kong Baptist University Ethics Committee on the Use of Human Subjects for Teaching
and Research. Subjects will be given their written informed consent before participating in
the study. Urine samples (50 ml each) will be collected the day before the administration
and at 0 to 3h, 3 to 6h, 6 to 9h and 9 to 12h after administration. Plasma and urine
fractions will be stored at -80°C until analysis.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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