HealthyPhase 1NCT00923000
Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs
A Phase 1 study testing Nalbuphine, Morphine and Morphine with Long dan xie gan tang in people with Healthy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and morphine with traditional Chinese herbs in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nalbuphine, Morphine and Morphine with Long dan xie gan tang
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2008to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei
Shung-Tai Ho, Professor, 886-2-87923100 ext. 19374
About this study
The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and morphine with traditional Chinese herbs in healthy volunteers.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
Nalbuphine 10mg with oral administration
MorphineDrug
Morphine 10mg with oral administration
Morphine with Long dan xie gan tangDrug
Morphine 10mg with oral administration
Nalbuphine with Long dan xie gan tangDrug
Nalbuphine 10mg with Long dan xie gan tang 3g tid with oral administration
Nubian with Long dan xie gan tangDrug
Nalbuphine 10mg with Long dan xie gan tang 3g with oral administration
| Study group | Role | What they receive |
|---|---|---|
| Nubian with Long dan xie gan tang 3g | Experimental | Not described Receives: Drug: Nubian with Long dan xie gan tang |
| Nalbuphine | Active comparator | Not described Receives: Drug: Nalbuphine |
| Morphine | Active comparator | Not described Receives: Drug: Morphine |
| Morphine with Long dan xie gan tang | Experimental | Not described Receives: Drug: Morphine with Long dan xie gan tang |
| Nubian with Long dan xie gan tang 3g tid | Experimental | Not described Receives: Drug: Nalbuphine with Long dan xie gan tang |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetic parameters
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Investigators
- Hung-Tai Ho, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923000
- Sponsor's protocol ID
- DDI-001
- Other IDs
- TSGHIRB096-02-015-A
- Status last verified
- Jun 2009
- First submitted
- 17 Jun 2009
- Last updated
- 19 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs
- ClinicalTrials.gov ID
- NCT00923000
- Acronym / sponsor ID
- DDI-001
- Conditions
- Healthy
- Keywords
- Herb Drug, volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nubian with Long dan xie gan tang 3g | Experimental | Drug: Nubian with Long dan xie gan tang |
| Nalbuphine | Active comparator | Drug: Nalbuphine |
| Morphine | Active comparator | Drug: Morphine |
| Morphine with Long dan xie gan tang | Experimental | Drug: Morphine with Long dan xie gan tang |
| Nubian with Long dan xie gan tang 3g tid | Experimental | Drug: Nalbuphine with Long dan xie gan tang |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NalbuphineNalbuphine 10mg with oral administration | Drug | Nalbuphine |
| MorphineMorphine 10mg with oral administration | Drug | Morphine |
| Morphine with Long dan xie gan tangMorphine 10mg with oral administration | Drug | Morphine with Long dan xie gan tang |
| Nalbuphine with Long dan xie gan tangNalbuphine 10mg with Long dan xie gan tang 3g tid with oral administration | Drug | Nubian with Long dan xie gan tang 3g tid |
| Nubian with Long dan xie gan tangNalbuphine 10mg with Long dan xie gan tang 3g with oral administration | Drug | Nubian with Long dan xie gan tang 3g |
Primary outcome
The pharmacokinetic parameters
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2009.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Tai Ho principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nalbuphine, Morphine and Morphine with Long dan xie gan tang in people with Healthy, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Rong Li (886-2-87923311 ext. 75000, crccrc@ndmctsgh.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pharmacokinetic parameters (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2009.