Could a pill replace the needle for pain relief?
NCT ID NCT02192151
First seen Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 2 times
Summary
This completed study tested an oral form of the painkiller nalbuphine, called PHN131, in 16 healthy adults. The goal was to see how the body absorbs and processes the pill compared to the injected version. Researchers also monitored safety by checking vital signs like blood pressure and heart rate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PHN131 (an oral form of nalbuphine hydrochloride)
- What this could lead to
- If successful, this could lead to an oral painkiller that is easier to take than injections.
- What could go wrong
- This is a very early, small study in healthy volunteers, not patients. It only measures how the drug moves through the body, not whether it actually relieves pain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
16 people
The number who actually took part.
- Started
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Oct 2011
- Finished
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Oct 2012
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
18
- Ages
-
20 to 40 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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General Clinical Research Center, Tri-service General Hospital
Taipei, 114, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.