Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

Study Overview
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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.

Official Title
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Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

Conditions
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Healthy

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nubian with Long dan xie gan tang 3g<br> | Drug: Nubian with Long dan xie gan tang<br>* Nalbuphine 10mg with Long dan xie gan tang 3g with oral administration<br>|
| Active Comparator: Nalbuphine<br> | Drug: Nalbuphine<br>* Nalbuphine 10mg with oral administration<br>|
| Active Comparator: Morphine<br> | Drug: Morphine<br>* Morphine 10mg with oral administration<br>|
| Experimental: Morphine with Long dan xie gan tang<br> | Drug: Morphine with Long dan xie gan tang<br>* Morphine 10mg with oral administration<br>|
| Experimental: Nubian with Long dan xie gan tang 3g tid<br> | Drug: Nalbuphine with Long dan xie gan tang<br>* Nalbuphine 10mg with Long dan xie gan tang 3g tid with oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic parameters |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herb Drug, volunteers