Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

• Sponsor: Tri-Service General Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00923000
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 5
• Duration (Months): 12
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: 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	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs
• Study Start Date: Dec 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2009
• Anticipated Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nubian with Long dan xie gan tang 3g	Drug: Nubian with Long dan xie gan tang; Nalbuphine 10mg with Long dan xie gan tang 3g with oral administration
Active Comparator: Nalbuphine	Drug: Nalbuphine; Nalbuphine 10mg with oral administration
Active Comparator: Morphine	Drug: Morphine; Morphine 10mg with oral administration
Experimental: Morphine with Long dan xie gan tang	Drug: Morphine with Long dan xie gan tang; Morphine 10mg with oral administration
Experimental: Nubian with Long dan xie gan tang 3g tid	Drug: Nalbuphine with Long dan xie gan tang; Nalbuphine 10mg with Long dan xie gan tang 3g tid with oral administration

Outcome Measures

Primary Outcome Measures

1. The pharmacokinetic parameters [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tri-Service General Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Tri-Service General Hospital

Investigators

• Principal Investigator: Hung-Tai Ho, Tri-Service General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00923000
• Other Study ID Numbers: DDI-001; TSGHIRB096-02-015-A
• First Posted: Jun 18, 2009
• Last Update Posted: Jun 19, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: Herb Drug; volunteers
• Additional relevant MeSH terms: Morphine; Nalbuphine

Study Results

No Results Posted as of Jun 19, 2009