Clinical Pharmacokinetics Study on Pikamilone | NCT00940186

Studies
Clinical Pharmacokinetics Study on Pikamilone

NCT00940186

Sponsor

Chinese Academy of Sciences

Status

Completed

Last Update Posted

Jul 15, 2009Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Not provided

Completion Date

Apr 2009Actual

First Submitted Date

Jul 14, 2009

First Submission Date that Met QC Criteria

Jul 14, 2009

First Posted Date

Jul 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2009

Last Update Posted Date

Jul 15, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
D F Zhong, PH.D	Shanghai Institute of Materia Medica, Chinese Academy of Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the second hospital to liaoning university of TCM		Shenyang	Liaoning	110034	China