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Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

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ClinicalTrials.gov Identifier: NCT00923000
Recruitment Status : Unknown
Verified June 2009 by Tri-Service General Hospital.
Recruitment status was:  Recruiting
First Posted : June 18, 2009
Last Update Posted : June 19, 2009
Sponsor:
Information provided by:
Tri-Service General Hospital

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

Condition or disease Intervention/treatment 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

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs
Study Start Date : December 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The pharmacokinetic parameters [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: June 19, 2009
Last Verified: June 2009

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

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