Clincosm LogoSign in Get a demo

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

Sponsor
Hong Kong Baptist University (Other)
Overall Status
Completed
CT.gov ID
NCT02359396
Collaborator
(none)
23
Enrollment
1
Location
3
Arms
9
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Oral Administration of a Chinese Proprietary Medicine, MZRW on Tolerability, Exposure and Pharmacokinetics in Healthy Subjects
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 5.0g of MZRW

The participants will receive 5.0g of MZRW at 9 am .

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.
Experimental: 7.5g of MZRW

The participants will receive 7.5g of MZRW at 9 am.

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.
Experimental: 10g of MZRW

The participants will receive 10g of MZRW at 9 am.

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.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability among Three Doses of MZRW [12 hours]

Secondary Outcome Measures

  1. Area under the plasma concentration versus time curve (AUC) [12 hours]

  2. the changes of plasma concentrations of MZRW ingredients in different time points [12 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Healthy voluteers

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Chinese Medicine, Hong Kong Baptist University Hong Kong Hong Kong China

Sponsors and Collaborators

  • Hong Kong Baptist University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ZhaoXiang Bian, Chair Professor, Director of Clinical Division,, Hong Kong Baptist University
ClinicalTrials.gov Identifier:
NCT02359396
Other Study ID Numbers:
  • HKBU/FRG2/13-14/025
First Posted:
Feb 10, 2015
Last Update Posted:
Aug 20, 2015
Last Verified:
Feb 1, 2015
Keywords provided by ZhaoXiang Bian, Chair Professor, Director of Clinical Division,, Hong Kong Baptist University
Randomized open-label study
Chinese Herbal
Constipation/drug therapy
Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Constipation

Study Results

No Results Posted as of Aug 20, 2015