Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Dec 2008
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2009
CompletedFirst Posted
Study publicly available on registry
June 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJune 19, 2009
June 1, 2009
1 year
June 17, 2009
June 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The pharmacokinetic parameters
24 hours
Study Arms (5)
Nubian with Long dan xie gan tang 3g
EXPERIMENTALNalbuphine
ACTIVE COMPARATORMorphine
ACTIVE COMPARATORMorphine with Long dan xie gan tang
EXPERIMENTALNubian with Long dan xie gan tang 3g tid
EXPERIMENTALInterventions
Morphine 10mg with oral administration
Nalbuphine 10mg with Long dan xie gan tang 3g tid with oral administration
Nalbuphine 10mg with Long dan xie gan tang 3g with oral administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tri-Service General Hospital
Taipei, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hung-Tai Ho
Tri-Service General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 17, 2009
First Posted
June 18, 2009
Study Start
December 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
June 19, 2009
Record last verified: 2009-06