Healthy
Conditions
Keywords
Bioavailability, Pharmacokinetics, Safety Evaluation
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.
Interventions
DRUGPhencynonate hydrochloride
2mg/tablet
Sponsors
PhytoHealth Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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 | 5 or 10 days |
| Safety Variables:AE/lab. exam./PE/Vital signs/ECG | 5 to 10 days |
Countries
Taiwan
Outcome results
None listed