Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

June 18, 2009 updated by: Tri-Service General Hospital
The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and morphine with traditional Chinese herbs in healthy volunteers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is a single center and open-label design to investigate the pharmacokinetic properties of Nubian, Nubian traditional Chinese herb combination dosage after single oral with oral administration, or morphine, morphine traditional Chinese herb combination dosage after single oral administration in healthy volunteers under fasting conditions.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
          • Shung-Tai Ho, Professor
          • Phone Number: 19374 886-2-87923100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Normal healthy adult subjects between 20-40 years of age
  • Body weight within 80-120% of ideal body weight
  • Acceptable medical history, physical examination and clinical laboratory determinations

Exclusion Criteria:

  • Recent history of drug or alcohol addiction or abuse
  • Donating greater than 150 ml of blood within two months prior to Period I
  • Taking any prescription medication or any nonprescription medication within 14 days prior to Period I doing
  • Receiving any investigational drug within 30 days prior to Period I dosing
  • Taking any drug known to induce or inhibit hepatic drug metabolism within 30 days prior to the beginning of the study
  • Any clinically significant diseases
  • History of allergic response to nalbuphine or related drugs and traditional Chinese herbs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Morphine
Drug: Morphine
Morphine 10mg with oral administration
Experimental: Nubian with Long dan xie gan tang 3g
Drug: Nubian with Long dan xie gan tang
Nalbuphine 10mg with Long dan xie gan tang 3g with oral administration
Active Comparator: Nalbuphine
Drug: Nalbuphine
Nalbuphine 10mg with oral administration
Experimental: Morphine with Long dan xie gan tang
Drug: Morphine with Long dan xie gan tang
Morphine 10mg with oral administration
Experimental: Nubian with Long dan xie gan tang 3g tid
Drug: Nalbuphine with Long dan xie gan tang
Nalbuphine 10mg with Long dan xie gan tang 3g tid with oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The pharmacokinetic parameters
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Investigators

  • Principal Investigator: Hung-Tai Ho, Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Estimate)

June 19, 2009

Last Update Submitted That Met QC Criteria

June 18, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDI-001
  • TSGHIRB096-02-015-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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