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

PhytoHealth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Phencynonate hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00861549

PH-CP005

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

cohort 1

Experimental group

Description:

1mg / 0.5 tablet

Treatment:

Drug: Phencynonate hydrochloride

cohort 2

Experimental group

Description:

2mg / 1 tablet; crossover with Phencynonate hydrochloride (2mg/1 tablet) made in China

Treatment:

Drug: Phencynonate hydrochloride

cohort 3

Experimental group

Description:

4mg / 2 tablets

Treatment:

Drug: Phencynonate hydrochloride