Study of PHN131 in Healthy Volunteers

May 28, 2026 updated by: PhytoHealth Corporation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

  1. 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.
  2. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • General Clinical Research Center, Tri-service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

18

Description

Inclusion Criteria:

Each subject must meet the following criteria to be enrolled in the study:

  1. Normal healthy adult subjects between 20 to 40 years of age.
  2. Body weight within 80 to 120% of ideal body weight. The ideal body weight is defined as: (subjects' height - 80) x 0.7

  3. 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.
  4. 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).
  5. 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.
  6. Acceptable urinalysis within two months prior to the study, which includes potential of Hydrogen (pH), urine glucose and protein.
  7. Signed the written informed consent to participate in this study.

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

  1. Recent history of drug or alcohol addiction or abuse.
  2. 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).
  3. History of allergic response(s) to nalbuphine or related drugs.
  4. History of clinically significant allergies including drug allergies or allergic bronchial asthma.
  5. Evidence of chronic or acute infectious disease.
  6. Any clinically significant illness or surgery during the 4 weeks prior to the Treatment Period of dose (as determined by the clinical investigator).
  7. Taking any drugs known to induce and/or inhibit hepatic drug metabolism within one month prior to the Treatment Period of dose.
  8. Receiving any investigational drug within one month prior to the Treatment Period of dose.
  9. Taking any prescription medication or any nonprescription medication within two weeks prior to the Treatment Period of dose.
  10. 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.
  11. 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.
  12. Any other medical reason(s) as determined by the clinical investigator.
  13. Patient is pregnant or breastfeeding. Women of childbearing potential have positive urine pregnancy test at baseline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety evaluation
Time Frame: 10 days
The safety evaluation will include the vital signs monitoring such as blood pressure, pulse rate, body temperature and respiratory rate in the treatment period.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PhytoHealth Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shung-Tai Ho, Ph.D, Tri-service General Hospital & National Defense Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PH-CP019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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