Clinical Pharmacokinetics Study on Pikamilone

NCT ID: NCT00940186

Last Updated: 2009-07-15

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

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-04-30

Brief Summary

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Study on the phamacokinetics of Pikamilone in healthy Chinese subject and provide informations for further phase II study.

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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pikamilone

No interventions assigned to this group

dosage

low dosage group: administrate pikamilone tablet 50 mg; middle dosage group: administrate pikamilone tablet 100 mg; hige dosage group: administrate pikamilone tablet 200 mg.

No interventions assigned to this group

tablet

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* nonsmokers and in good health
* weight: BMI: 19-24
* written informed consent was finished.

Exclusion Criteria

* disease
* taking any drug, alcohol, foods containing caffeine, or grapefruits and juice before study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese Academy of Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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shanghai institute of materia medica

Principal Investigators

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D F Zhong, PH.D

Role: STUDY_CHAIR

Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Locations

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the second hospital to liaoning university of TCM

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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SIMM-DMPK-080901

Identifier Type: -

Identifier Source: org_study_id

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