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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Phencynonate hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 5 or 10 days | 
| Safety Variables:AE/lab. exam./PE/Vital signs/ECG |  | 5 to 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability, Pharmacokinetics, Safety Evaluation