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

This study has been completed.
Sponsor:
Information provided by:
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT00861549
First received: March 10, 2009
Last updated: September 13, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: Phencynonate hydrochloride
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Bioavailability, Pharmacokinetics and Safety Evaluation of Phencynonate Hydrochloride in Healthy Volunteers

Further study details as provided by PhytoHealth Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Safety Variables:AE/lab. exam./PE/Vital signs/ECG [ Time Frame: 5 to 10 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: August 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861549

Locations
Taiwan
General Clinical Research Center for New Drug Trial, Tri-Service General Hospital
Taipei, Taiwan, 114
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
Principal Investigator: Yaoh S Lin, M.D. Yaoh-Shiang Lin
  More Information

No publications provided

Responsible Party: PhytoHealth Corporation
ClinicalTrials.gov Identifier: NCT00861549     History of Changes
Obsolete Identifiers: NCT00766428, NCT00926679
Other Study ID Numbers: PH-CP005
Study First Received: March 10, 2009
Last Updated: September 13, 2011
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

Keywords provided by PhytoHealth Corporation:
Bioavailability
Pharmacokinetics
Safety Evaluation

ClinicalTrials.gov processed this record on May 22, 2013