Bioavailability, Pharmacokinetics and Safety Evaluation of Phencynonate Hydrochloride in Healthy Volunteers

June 2, 2025 updated by: PhytoHealth Corporation
The purpose of this study is to evaluate the bioavailability of two formulations (Taiwan and China mainland) of phencynonate hydrochloride tablets and to generate pharmacokinetic and safety profiles of phencynonate hydrochloride in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • General Clinical Research Center for New Drug Trial, Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects must have signed and dated informed consent form.
  2. Subjects must be ≧ 18 and ≦ 40 years old, healthy, non-smoking male.
  3. Subjects with body weight within ± 20% ideal body weight
  4. Subjects with urinalysis data within acceptable range, including pH, blood, glucose and protein
  5. Subjects with laboratory evaluations data within acceptable range, including serum chemistry examinations (glucose, total cholesterol, TG, SGOT, SGPT, GSP, alkaline phosphatase, total bilirubin, total protein, albumin, r-GT, BUN, creatinine, uric acid) and hematology (complete blood count and platelets)
  6. Subjects with acceptable ECG and chest x-ray

Exclusion Criteria:

  1. Subjects had taken any drugs within 14 days prior to screening.
  2. Subjects with history of glaucoma
  3. Subjects with history of ileus
  4. Subjects with history of benign prostate hypertrophy with urine retention
  5. Subjects with history of myasthenia gravis
  6. Subjects with history of asthma
  7. Subject with history of any other medical conditions that, in the opinion of the investigator, compromised subject safety or ability to comply with study procedures
  8. Subjects with history of drug or alcohol addiction or abuse within 1 year prior to screening
  9. Subjects with hypersensitivity to phencynonate hydrochloride or other drugs with similar chemical structure
  10. Subjects had donated blood more than 250 mL within the pervious 3 months prior to study
  11. Subjects had received any investigational drugs within 1 month prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cohort 1
1mg / 0.5 tablet
Drug: Phencynonate hydrochloride
2mg/tablet
Experimental: cohort 2
2mg / 1 tablet; crossover with Phencynonate hydrochloride (2mg/1 tablet) made in China
Drug: Phencynonate hydrochloride
2mg/tablet
Experimental: cohort 3
4mg / 2 tablets
Drug: Phencynonate hydrochloride
2mg/tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK parameters(1)Cmax,Tmax,Elimination half-life,AUC,Vd/F,Clt/F,MRT,relative BA and percentage of protein binding of plasma PCNH and its metabolite (2) D∞(u)and Clr of urine PCNH and its metabolite
Time Frame: 5 or 10 days
5 or 10 days
Safety Variables:AE/lab. exam./PE/Vital signs/ECG
Time Frame: 5 to 10 days
5 to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PhytoHealth Corporation

Investigators

  • Principal Investigator: Yaoh S Lin, M.D., Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimated)

March 13, 2009

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PH-CP005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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