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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Oral Administration of a Chinese Proprietary Medicine, MZRW on Tolerability, Exposure and Pharmacokinetics in Healthy Subjects

Conditions
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Functional Constipation, Gastrointestinal Disorders

Intervention / Treatment
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* Drug: MZRW


Participation Criteria
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Eligibility Criteria
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Healthy voluteers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5.0g of MZRW<br>The participants will receive 5.0g of MZRW at 9 am . | Drug: MZRW<br>* 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.<br>|
| Experimental: 7.5g of MZRW<br>The participants will receive 7.5g of MZRW at 9 am. | Drug: MZRW<br>* 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.<br>|
| Experimental: 10g of MZRW<br>The participants will receive 10g of MZRW at 9 am. | Drug: MZRW<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability among Three Doses of MZRW |  | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) |  | 12 hours | 
| the changes of plasma concentrations of MZRW ingredients in different time points |  | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized open-label study, Chinese Herbal, Constipation/drug therapy