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Clinical Pharmacokinetics Study on Pikamilone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00940186
First Posted: July 15, 2009
Last Update Posted: July 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chinese Academy of Sciences
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Chinese Academy of Sciences
  More Information

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
First Submitted: July 14, 2009
First Posted: July 15, 2009
Last Update Posted: July 15, 2009
Last Verified: July 2009