Analgesia DisorderNCT02192151
Study of PHN131 in Healthy Volunteers
An observational study of Analgesia Disorder, run by PhytoHealth Corporation at 1 site in Taiwan.
Trial summary
To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability of PHN131 in healthy volunteers Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia Disorder
- How many people
- 16 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2011to Oct 2012
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 18
Who may be able to join
- Each subject must meet the following criteria to be enrolled in the study:
- Normal healthy adult subjects between 20 to 40 years of age.
- Body weight within 80 to 120% of ideal body weight. The ideal body weight is defined as: (subjects' height - 80) x 0.7
- Acceptable medical history and physical examination including:
- Normal chest X-ray and ECG results within six months prior to the Treatment Period of dose.
- No particular clinical significance in general disease history within two months prior to the Treatment Period of dose.
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- Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to the Treatment Period of dose, which includes Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Gamma-Glutamyl Transferase (gamma-GT), alkaline phosphatase, total bilirubin, albumin glucose, Blood Urea Nitrogen (BUN), uric acid, creatinine, total cholesterol and triglyceride (TG).
- Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), white blood cells and platelets.
- Acceptable urinalysis within two months prior to the study, which includes potential of Hydrogen (pH), urine glucose and protein.
- Signed the written informed consent to participate in this study.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Recent history of drug or alcohol addiction or abuse.
- A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
- History of allergic response(s) to nalbuphine or related drugs.
- History of clinically significant allergies including drug allergies or allergic bronchial asthma.
- Evidence of chronic or acute infectious disease.
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- Any clinically significant illness or surgery during the 4 weeks prior to the Treatment Period of dose (as determined by the clinical investigator).
- Taking any drugs known to induce and/or inhibit hepatic drug metabolism within one month prior to the Treatment Period of dose.
- Receiving any investigational drug within one month prior to the Treatment Period of dose.
- Taking any prescription medication or any nonprescription medication within two weeks prior to the Treatment Period of dose.
- Donating greater than 150 ml of blood within two months prior to the Treatment Period of dose or donating plasma (e.g. plasmapheresis) within 14 days prior to the Treatment Period of dose. All subjects will be advised not to donate blood for 4 weeks after completing the study.
- Consumption of caffeine, xanthine-containing products (i.e. coffee, tea, caffeine-containing sodas, colas and chocolates, etc.) and/or alcohol at least 48 hours prior to day on which dosing is scheduled and during the periods when blood samples are being collected.
- Any other medical reason(s) as determined by the clinical investigator.
- Patient is pregnant or breastfeeding. Women of childbearing potential have positive urine pregnancy test at baseline.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
General Clinical Research Center, Tri-service General Hospital
Taipei, 114
About this study
Official title: The Pharmacokinetic and Bioavailability Studies of PHN131, an Oral Formulation of Nalbuphine Hydrochloride, in Healthy Volunteers
To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability of PHN131 in healthy volunteers
Read the detailed description
- Efficacy endpoint(s): the pharmacokinetic properties and bioavailability of PHN131 The efficacy endpoint will be the pharmacokinetic properties after administered PHN131 such as the concentration of nalbuphine in plasma and pharmacokinetic parameters of PHN131 analyzed from the concentration of nalbuphine in plasma. The bioavailability of PHN131 will be calculated from the pharmacokinetic parameters of PHN131 and Nubain® injection.
- Safety evaluation:
The safety evaluation will include the vital signs monitoring such as blood pressure, pulse rate, body temperature and respiratory rate in the treatment period.
- Conditions
- Analgesia Disorder
- Keywords
- Analgesic, Narcotics, Opioids, Non-scheduled substance
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint(s)
The pharmacokinetic properties and bioavailability of PHN131 The efficacy endpoint will be the pharmacokinetic properties after administered PHN131 such as the concentration of nalbuphine in plasma and pharmacokinetic parameters of PHN131 analyzed from the concentration of nalbuphine in plasma. The bioavailability of PHN131 will be calculated from the pharmacokinetic parameters of PHN131 and Nubain® injection.
Measured: 10 days
Secondary outcomes (1)
Safety evaluation
The safety evaluation will include the vital signs monitoring such as blood pressure, pulse rate, body temperature and respiratory rate in the treatment period.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startOct 2011
- Primary completionOct 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia DisorderStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shung-Tai Ho, Ph.D, Principal investigator, Tri-service General Hospital & National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192151
- Sponsor's protocol ID
- PH-CP019
- Status last verified
- Sep 2026
- First submitted
- 24 Nov 2013
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetic and Bioavailability Studies of PHN131, an Oral Formulation of Nalbuphine Hydrochloride, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02192151
- Acronym / sponsor ID
- PH-CP019
- Conditions
- Analgesia Disorder
- Keywords
- Analgesic, Narcotics, Opioids, Non-scheduled substance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2011 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Jul 2014 (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.
To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability of PHN131 in healthy volunteers
Detailed description
- Efficacy endpoint(s): the pharmacokinetic properties and bioavailability of PHN131 The efficacy endpoint will be the pharmacokinetic properties after administered PHN131 such as the concentration of nalbuphine in plasma and pharmacokinetic parameters of PHN131 analyzed from the concentration of nalbuphine in plasma. The bioavailability of PHN131 will be calculated from the pharmacokinetic parameters of PHN131 and Nubain® injection.
- Safety evaluation:
The safety evaluation will include the vital signs monitoring such as blood pressure, pulse rate, body temperature and respiratory rate in the treatment period.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 18
Key inclusion criteria (10 listed)
- Normal healthy adult subjects between 20 to 40 years of age.
- Body weight within 80 to 120% of ideal body weight. The ideal body weight is defined as: (subjects' height - 80) x 0.7
- Acceptable medical history and physical examination including:
- Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to the Treatment Period of dose, which includes Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Gamma-Glutamyl Transferase (gamma-GT), alkaline phosphatase, total bilirubin, albumin glucose, Blood Urea Nitrogen (BUN), uric acid, creatinine, total cholesterol and triglyceride (TG).
- Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), white blood cells and platelets.
Key exclusion criteria (14 listed)
- Recent history of drug or alcohol addiction or abuse.
- A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
- History of allergic response(s) to nalbuphine or related drugs.
- History of clinically significant allergies including drug allergies or allergic bronchial asthma.
- Evidence of chronic or acute infectious disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy endpoint(s)
Time frame: 10 days
The pharmacokinetic properties and bioavailability of PHN131 The efficacy endpoint will be the pharmacokinetic properties after administered PHN131 such as the concentration of nalbuphine in plasma and pharmacokinetic parameters of PHN131 analyzed from the concentration of nalbuphine in plasma. The bioavailability of PHN131 will be calculated from the pharmacokinetic parameters of PHN131 and Nubain® injection.
1 secondary outcome
Safety evaluation
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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.
Shung-Tai Ho, Ph.D principal investigator
Tri-service General Hospital & National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia Disorder, run by PhytoHealth Corporation 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 10 inclusion and 14 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: finished, as of the sponsor's last update on 21 Sep 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint(s) (time frame: 10 days). 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 21 Sep 2026.