Status:
COMPLETED
Bioavailability, Pharmacokinetics and Safety Evaluation of Phencynonate Hydrochloride in Healthy Volunteers
Lead Sponsor:
PhytoHealth Corporation
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
PHASE1
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00861549
Start Date
August 1 2008
End Date
January 1 2010
Last Update
June 4 2025
Active Locations (1)
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1
General Clinical Research Center for New Drug Trial, Tri-Service General Hospital
Taipei, Taiwan, 114