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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-01-31

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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cohort 1

1mg / 0.5 tablet

Group Type EXPERIMENTAL

Phencynonate hydrochloride

Intervention Type DRUG

2mg/tablet

cohort 2

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

Group Type EXPERIMENTAL

Phencynonate hydrochloride

Intervention Type DRUG

2mg/tablet

cohort 3

4mg / 2 tablets

Group Type EXPERIMENTAL

Phencynonate hydrochloride

Intervention Type DRUG

2mg/tablet

Interventions

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Phencynonate hydrochloride

2mg/tablet

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes