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

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