Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

NCT ID: NCT00923000

Last Updated: 2009-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Nubian with Long dan xie gan tang 3g

Group Type EXPERIMENTAL

Nubian with Long dan xie gan tang

Intervention Type DRUG

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

Nalbuphine

Group Type ACTIVE_COMPARATOR

Nalbuphine

Intervention Type DRUG

Nalbuphine 10mg with oral administration

Morphine

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine 10mg with oral administration

Morphine with Long dan xie gan tang

Group Type EXPERIMENTAL

Morphine with Long dan xie gan tang

Intervention Type DRUG

Morphine 10mg with oral administration

Nubian with Long dan xie gan tang 3g tid

Group Type EXPERIMENTAL

Nalbuphine with Long dan xie gan tang

Intervention Type DRUG

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

Interventions

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Nalbuphine

Nalbuphine 10mg with oral administration

Intervention Type DRUG

Morphine

Morphine 10mg with oral administration

Intervention Type DRUG

Morphine with Long dan xie gan tang

Morphine 10mg with oral administration

Intervention Type DRUG

Nalbuphine with Long dan xie gan tang

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

Intervention Type DRUG

Nubian with Long dan xie gan tang

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tri-Service General Hospital

Principal Investigators

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Hung-Tai Ho

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

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Tri-Service General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Rong Li

Role: CONTACT

886-2-87923311 ext. 75000

Facility Contacts

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Shung-Tai Ho, Professor

Role: primary

886-2-87923100 ext. 19374

Other Identifiers

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TSGHIRB096-02-015-A

Identifier Type: -

Identifier Source: secondary_id

DDI-001

Identifier Type: -

Identifier Source: org_study_id

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