Clinical Pharmacokinetics Study on Pikamilone
This study has been completed.
Sponsor:
Chinese Academy of Sciences
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
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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 May 19, 2013