The Pharmacokinetics Study of Concentrated Herbal Formula... | NCT00329212

Studies
The Pharmacokinetics Study of Concentrated Herbal Formula and Traditional Herbal Decoctions in Humans

NCT00329212

Sponsor

Committee on Chinese Medicine and Pharmacy

Status

Completed

Last Update Posted

Nov 15, 2006Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Healthy

Interventions

San Huang Xie Jin Tang

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

Nov 2006

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 23, 2006

First Submission Date that Met QC Criteria

May 23, 2006

First Posted Date

May 24, 2006Estimated

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

Nov 14, 2006

Last Update Posted Date

Nov 15, 2006Estimated

Description Module

Brief Summary

The purpose of this study is to investigate the pharmacokinetics in humans of San Huang Xie Jin Tang (SHXJT) and evaluate the bioequivalence between herbal concentrate and traditional decoction.

Detailed Description

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

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
San Huang Xie Jin Tang	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The volunteers about 6~8 persons should be aged from 20 to 35 years old with a body weight between 50~80 kg, no marriage and have a healthy body condition.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Y C Hou, Professor	School of Chinese Medicine, China Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Committee on Chinese Medicine and Pharmacy, Department of Health		Taipei	Taiwan		China