Status:
UNKNOWN
Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs
Lead Sponsor:
Tri-Service General Hospital
Conditions:
Healthy
Eligibility:
FEMALE
20-40 years
Phase:
PHASE1
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.
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 administrati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00923000
Start Date
December 1 2008
End Date
December 1 2009
Last Update
June 19 2009
Active Locations (1)
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1
Tri-Service General Hospital
Taipei, Taiwan