Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs
Information source: Tri-Service General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: 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 (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Tri-Service General Hospital Official(s) and/or principal investigator(s): Hung-Tai Ho, Principal Investigator, Affiliation: Tri-Service General Hospital
Overall contact: Yu-Rong Li, Phone: 886-2-87923311, Ext: 75000, Email: crccrc@ndmctsgh.edu.tw
Summary
The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and
morphine with traditional Chinese herbs in healthy volunteers.
Clinical Details
Official title: Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: The pharmacokinetic parameters
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
Minimum age: 20 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
Yu-Rong Li, Phone: 886-2-87923311, Ext: 75000, Email: crccrc@ndmctsgh.edu.tw
Tri-Service General Hospital, Taipei, Taiwan; Recruiting Shung-Tai Ho, Professor, Phone: 886-2-87923100, Ext: 19374
Additional Information
Starting date: December 2008
Last updated: June 18, 2009
|