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Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Tri-Service General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tri-Service General Hospital
ClinicalTrials.gov Identifier:
NCT00923000
First received: June 17, 2009
Last updated: June 18, 2009
Last verified: June 2009
  Purpose

The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and morphine with traditional Chinese herbs in healthy volunteers.


Condition Intervention Phase
Healthy
Drug: Nalbuphine
Drug: Morphine
Drug: Morphine with Long dan xie gan tang
Drug: Nalbuphine with Long dan xie gan tang
Drug: Nubian with Long dan xie gan tang
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

Resource links provided by NLM:


Further study details as provided by Tri-Service General Hospital:

Primary Outcome Measures:
  • The pharmacokinetic parameters [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Morphine Drug: Morphine
Morphine 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00923000

Contacts
Contact: Yu-Rong Li 886-2-87923311 ext 75000 crccrc@ndmctsgh.edu.tw

Locations
Taiwan
Tri-Service General Hospital Recruiting
Taipei, Taiwan
Contact: Shung-Tai Ho, Professor    886-2-87923100 ext 19374      
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
Principal Investigator: Hung-Tai Ho Tri-Service General Hospital
  More Information

No publications provided

Responsible Party: Shung-Tai Ho/Professor, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT00923000     History of Changes
Other Study ID Numbers: DDI-001, TSGHIRB096-02-015-A
Study First Received: June 17, 2009
Last Updated: June 18, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Tri-Service General Hospital:
Herb Drug
volunteers

Additional relevant MeSH terms:
Narcotic Antagonists
Narcotics
Morphine
Nalbuphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014