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A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics

NCT02359396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-08-20

No results posted yet for this study

Summary

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.

Conditions

  • Functional Constipation
  • Gastrointestinal Disorders

Interventions

DRUG

MZRW

MZRWs is composed of Fructus Cannabis (HuoMaRen), Radix et Rhizoma Rhei (DaHuang), Radix Paeoniae Alba (BaiShao), Semen Armeniacae Amarum (KuXingRen), Fructus Aurantii Immaturus (ZhiShi) and Cortex Magnoliae Officinalis (HouPo). All MZRW granules will be prepared by PuraPharm International (H.K.) Limited. The entire manufacturing process, from authenticating the raw materials to the final products, is in strict compliance with the standards of Good Manufactory Practice (GMP) and Chinese Pharmacopoeia.

Sponsors & Collaborators

  • Hong Kong Baptist University

    lead OTHER

Principal Investigators

  • Zhao Xiang Bian, MD, Ph. D · School of Chinese Medicine, Hong Kong Baptist University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02359396 on ClinicalTrials.gov