Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

Phase 1

• Conditions: Healthy
• Interventions: Drug: Nubian with Long dan xie gan tang; Drug: Morphine; Drug: Morphine with Long dan xie gan tang; Drug: Nalbuphine with Long dan xie gan tang; Drug: Nalbuphine

• Registration Number: NCT00923000
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-12
• Status Verified: 2009-06
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Last Update Submitted: 2009-06-18
• Last Update Posted: 2009-06-19
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nubian with Long dan xie gan tang 3g	Nubian with Long dan xie gan tang	-
Morphine	Morphine	-
Morphine with Long dan xie gan tang	Morphine with Long dan xie gan tang	-
Nubian with Long dan xie gan tang 3g tid	Nalbuphine with Long dan xie gan tang	-
Nalbuphine	Nalbuphine	-

Primary Outcome Measures

Name	Time	Method
The pharmacokinetic parameters	24 hours

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan