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

Hong Kong Baptist University

Status and phase: Completed; Phase 1

Conditions: Functional Constipation; Gastrointestinal Disorders

Treatments: Drug: MZRW

Study type: Interventional

Funder types: Other

Identifiers

NCT02359396

HKBU/FRG2/13-14/025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy voluteers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 3 patient groups

5.0g of MZRW

Experimental group

Description:

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

Treatment:

Drug: MZRW

7.5g of MZRW

Experimental group

Description:

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

Treatment:

Drug: MZRW

10g of MZRW

Experimental group

Description:

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

Treatment:

Drug: MZRW