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

Phase 1

Completed

• Conditions: Gastrointestinal Disorders; Functional Constipation
• Interventions: Drug: MZRW

• Registration Number: NCT02359396
• Lead Sponsor: Hong Kong Baptist University

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-01-27
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-10
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5.0g of MZRW	MZRW	The participants will receive 5.0g of MZRW at 9 am .
10g of MZRW	MZRW	The participants will receive 10g of MZRW at 9 am.
7.5g of MZRW	MZRW	The participants will receive 7.5g of MZRW at 9 am.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability among Three Doses of MZRW	12 hours

Secondary Outcome Measures

Name	Time	Method
the changes of plasma concentrations of MZRW ingredients in different time points	12 hours
Area under the plasma concentration versus time curve (AUC)	12 hours

Trial Locations

Locations (1)

School of Chinese Medicine, Hong Kong Baptist University; 🇨🇳 Hong Kong, Hong Kong, China