Clinical Trials Logo
  1. Home
  2. Functional Constipation
  3. NCT02359396

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

Functional Constipation Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02359396
Study type Interventional
Source Hong Kong Baptist University
Contact
Status Completed
Phase Phase 1
Start date November 2014
Completion date August 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT04506801 - The Effect of Probiotics on Functional Constipation in the Elderly N/A
Completed NCT04620161 - A Proof of Concept Study of Pradigastat in Patients With Functional Constipation Phase 2
Active, not recruiting NCT02361749 - Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation Phase 4
Completed NCT03054805 - The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation Phase 4
Not yet recruiting NCT01913665 - The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation N/A
Completed NCT01622972 - Mode of Action of Moviprep Phase 4
Completed NCT01348152 - Effect of TU-100 in Patients With Functional Constipation Phase 2
Completed NCT01212146 - Probiotic-enriched Artichoke in Functional Constipation N/A
Completed NCT04231162 - Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation N/A
Not yet recruiting NCT03639142 - Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children Phase 3
Recruiting NCT04918329 - Functional Digestive Disorders Observatory
Completed NCT02592200 - Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women N/A
Completed NCT03707002 - Effect of scFOS on Increase in Stool Frequency in Constipated People N/A
Recruiting NCT06083311 - The Efficacy of a Probiotic for Functional Constipation (FC) N/A
Completed NCT04110145 - Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation Phase 2
Recruiting NCT06196073 - Visceral Osteopathy in Functional Constipation N/A
Active, not recruiting NCT04026113 - Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) Phase 3
Completed NCT01847950 - Effects of scFOS on Stool Frequency in People With Functionnal Constipation N/A
Recruiting NCT01274793 - Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy Phase 1
Enrolling by invitation NCT04166058 - Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C Phase 3