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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014