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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Phencynonate hydrochloride

• Registration Number: NCT00861549
• Lead Sponsor: PhytoHealth Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
cohort 1	Phencynonate hydrochloride	1mg / 0.5 tablet
cohort 2	Phencynonate hydrochloride	2mg / 1 tablet; crossover with Phencynonate hydrochloride (2mg/1 tablet) made in China
cohort 3	Phencynonate hydrochloride	4mg / 2 tablets

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

General Clinical Research Center for New Drug Trial, Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan