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

NCT00861549 | Completed Phase 1

• 1 other identifier: PH-CP005
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioavailability; Pharmacokinetics; Safety Evaluation

Outcome Measures

Primary Outcomes (2)

• 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

  5 or 10 days

• Safety Variables:AE/lab. exam./PE/Vital signs/ECG

  5 to 10 days

Study Arms (3)

cohort 1

EXPERIMENTAL

1mg / 0.5 tablet

Drug: Phencynonate hydrochloride

cohort 2

EXPERIMENTAL

2mg / 1 tablet; crossover with Phencynonate hydrochloride (2mg/1 tablet) made in China

Drug: Phencynonate hydrochloride

cohort 3

EXPERIMENTAL

4mg / 2 tablets

Drug: Phencynonate hydrochloride

Interventions

Phencynonate hydrochloride DRUG

2mg/tablet

cohort 1; cohort 2; cohort 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must have signed and dated informed consent form.
• Subjects must be ≧ 18 and ≦ 40 years old, healthy, non-smoking male.
• Subjects with body weight within ± 20% ideal body weight
• Subjects with urinalysis data within acceptable range, including pH, blood, glucose and protein
• 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)
• Subjects with acceptable ECG and chest x-ray

You may not qualify if:

• Subjects had taken any drugs within 14 days prior to screening.
• Subjects with history of glaucoma
• Subjects with history of ileus
• Subjects with history of benign prostate hypertrophy with urine retention
• Subjects with history of myasthenia gravis
• Subjects with history of asthma
• 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
• Subjects with history of drug or alcohol addiction or abuse within 1 year prior to screening
• Subjects with hypersensitivity to phencynonate hydrochloride or other drugs with similar chemical structure
• Subjects had donated blood more than 250 mL within the pervious 3 months prior to study
• Subjects had received any investigational drugs within 1 month prior to screening

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (1)

General Clinical Research Center for New Drug Trial, Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Interventions

3-methyl-3-azabicyclo(3,3,1)nonanyl-9-alpha-yl-alpha-cyclopentyl-alpha-phenyl-alpha-glycolate

Study Officials

• Yaoh S Lin, M.D.

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 13, 2009
• Study Start: August 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

TW (1)