Study of PHN131 in Healthy Volunteers (NCT02192151) | Clinical Trial Compass
CompletedNot Applicable
Study of PHN131 in Healthy Volunteers
Taiwan16 participantsStarted 2011-10
Plain-language summary
To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability of PHN131 in healthy volunteers
Who can participate
Age range
20 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Exclusion criteria
. Recent history of drug or alcohol addiction or abuse.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. 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.