Clinical Pharmacokinetics Study on Pikamilone

This study has been completed.
Sponsor:
Information provided by:
Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT00940186
First received: July 14, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Pharmacokinetics Study on Pikamilone

Further study details as provided by Chinese Academy of Sciences:

Biospecimen Retention:   Samples Without DNA

plasma


Enrollment: 30
Study Start Date: March 2009
Study Completion Date: April 2009
Groups/Cohorts
pikamilone
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.
tablet

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

15 male subjects and 15 female subjects were enrolled in this study. They were divided into three groups by random and each group contained 5 male and 5 female subjects.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940186

Locations
China, Liaoning
the second hospital to liaoning university of TCM
Shenyang, Liaoning, China, 110034
Sponsors and Collaborators
Chinese Academy of Sciences
Investigators
Study Chair: D F Zhong, PH.D Shanghai Institute of Materia Medica
  More Information

No publications provided

Responsible Party: center for drug metabolism and pharmacokinetics, shanghai institute of materia medica
ClinicalTrials.gov Identifier: NCT00940186     History of Changes
Other Study ID Numbers: SIMM-DMPK-080901
Study First Received: July 14, 2009
Last Updated: July 14, 2009
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on April 16, 2014