Evaluating the effects of Panadol® and SafeTynadol® on healthy volunteers

A Partial Randomized, Single-blind or Open-label, Dose-escalation With Multiple-dose Design Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With Panadol® and SafeTynadol® in Healthy Volunteers

This study is testing how two different forms of acetaminophen, Panadol® and SafeTynadol®, affect healthy volunteers to see how safe they are and how the body processes them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 20 Years to 50 Years
• Sex: All
• Sponsor: Sinew Pharma Inc. (Industry-sponsored)
• Locations: 1 site (Taipei City, Neihu District)
• Trial ID: NCT05563961 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetics of two acetaminophen formulations, Panadol® and SafeTynadol®, in healthy volunteers. Participants will be divided into cohorts, with the first two cohorts receiving fixed doses of each formulation, while subsequent cohorts will undergo dose escalation of SafeTynadol® to assess safety and potential hepatotoxicity. The study aims to balance male and female participants and will monitor various health parameters throughout the dosing period.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 20-50 with a body weight within 80-120% of their ideal body weight.

Not a fit: Patients with a history of liver disease or significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into safer dosing strategies for acetaminophen formulations, potentially reducing the risk of liver toxicity.

How similar studies have performed: While studies on acetaminophen have been conducted, this specific dose-escalation approach with SafeTynadol® is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Normal healthy adult subjects between 20-50 years of age.
* Body weight within 80-120% of ideal body weight.

  * Male Ideal body weight = (height - 80) x 0.7
  * Female Ideal body weight = (height - 70) x 0.6
* Acceptable medical history and physical examination including:
* normal ECG results within six months prior to dosing.
* no particular clinical significance in general disease history within two months prior to dosing.
* Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to dosing, which includes AST (SGOT), ALT (SGPT), r-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol, triglyceride (TG), PT(INR) and OGSP.
* Acceptable hematology within two months prior to dosing, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
* Acceptable urinalysis within two months prior to dosing, which includes pH, blood, glucose and protein.
* Signed the written informed consent to participate in this study

Exclusion Criteria:

* History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years.
* A clinically significant disorder involving the allergy, cardiovascular, respiratory, renal, gastrointestinal/hepatic, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
* History of allergic response(s) to acetaminophen, mannitol, sucralose or related drugs.
* History of clinically significant allergies including drug allergies or allergic bronchial asthma.
* Evidence of chronic or acute infectious diseases.
* Any clinically significant illness or surgery during the two month prior to dosing (as determined by the clinical investigator).
* Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
* Receiving any investigational drug within one month prior to dosing.
* Taking any prescription medication or any nonprescription medication within two weeks prior to dosing.
* Donating greater than 150 ml of blood within two months prior to dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to dosing.
* Consumption of caffeine, xanthine-containing products (i.e. coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol within 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
* Any other medical reason as determined by the clinical investigator.
* Subject is pregnant or breastfeeding.
* Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, intrauterine device (IUD), barrier device or abstinence) throughout the study.

Where this trial is running

Taipei City, Neihu District

• Tri-Service General Hospital — Taipei City, Neihu District, Taiwan (Recruiting)

Study contacts

• Study coordinator: ChengHuei Mr. Hsiong, Vice President

Conditions Hepatitis; Pharmacology; acetaminophen; acute liver failure