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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

Page last updated: August 23, 2015

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