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

NCT ID: NCT02359396

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-08-31

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.

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.

Conditions

Functional Constipation; Gastrointestinal Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5.0g of MZRW

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

Group Type: EXPERIMENTAL

MZRW

Intervention Type: DRUG

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.

7.5g of MZRW

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

Group Type: EXPERIMENTAL

MZRW

Intervention Type: DRUG

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.

10g of MZRW

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

Group Type: EXPERIMENTAL

MZRW

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Healthy voluteers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hong Kong Baptist University

OTHER

Sponsor Role: lead

Responsible Party

ZhaoXiang Bian

Chair Professor, Director of Clinical Division,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhao Xiang Bian, MD, Ph. D

Role: PRINCIPAL_INVESTIGATOR

School of Chinese Medicine, Hong Kong Baptist University

Locations

School of Chinese Medicine, Hong Kong Baptist University

Hong Kong, Hong Kong, China

Countries

China

Other Identifiers

HKBU/FRG2/13-14/025

Identifier Type: -

Identifier Source: org_study_id