Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

Tri-Service General Hospital

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Morphine with Long dan xie gan tang; Drug: Nalbuphine; Drug: Morphine; Drug: Nalbuphine with Long dan xie gan tang; Drug: Nubian with Long dan xie gan tang

Study type: Interventional

Funder types: Other

Identifiers

NCT00923000

DDI-001

TSGHIRB096-02-015-A

Details and patient eligibility

About

The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and morphine with traditional Chinese herbs in healthy volunteers.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 5 patient groups

Nubian with Long dan xie gan tang 3g

Experimental group

Treatment:

Drug: Nubian with Long dan xie gan tang

Nalbuphine

Active Comparator group

Treatment:

Drug: Nalbuphine

Morphine

Active Comparator group

Treatment:

Drug: Morphine

Morphine with Long dan xie gan tang

Experimental group

Treatment:

Drug: Morphine with Long dan xie gan tang

Nubian with Long dan xie gan tang 3g tid

Experimental group

Treatment:

Drug: Nalbuphine with Long dan xie gan tang