Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00923000

Enrollment

Registered

2009-06-18

Start date

2008-12-31

Completion date

2009-12-31

Last updated

2009-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Herb Drug, volunteers

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.

Interventions

DRUGNalbuphine

Nalbuphine 10mg with oral administration

DRUGMorphine

Morphine 10mg with oral administration

DRUGMorphine with Long dan xie gan tang

Morphine 10mg with oral administration

DRUGNalbuphine with Long dan xie gan tang

Nalbuphine 10mg with Long dan xie gan tang 3g tid with oral administration

DRUGNubian with Long dan xie gan tang

Nalbuphine 10mg with Long dan xie gan tang 3g with oral administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame
The pharmacokinetic parameters	24 hours

Countries

Taiwan

Contacts

Primary ContactYu-Rong Li

crccrc@ndmctsgh.edu.tw886-2-87923311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026