Status:
COMPLETED
A Randomized, Single-blind, Parallel Group and Multiple - Dose Design Study
Lead Sponsor:
Sinew Pharma Inc.
Conditions:
Acetaminophen Toxicity
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief Summary
To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers.
Detailed Description
Acetaminophen (AAP) is the most popular used analgesic/ antipyretic drug with serious hepatotoxic adverse effects; suicidal or unintentional overdose of AAP-induced hepatotoxicity. Cytochrome P450 2E1...
Eligibility Criteria
Inclusion
- 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) \* 0.7 Female: Ideal body weight = (height - 70) \* 0.6
- Acceptable medical history and physical examination including:
- normal ECG results within six months prior to Period I (or Period III or Period V) dosing.
- no particular clinical significance in general disease history within two months prior to Period I (or Period III or Period V) dosing.
- Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I (or Period III or Period V) dosing, which includes AST (SGOT), ALT (SGPT), r-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol, triglyceride (TG) and oral galactose single point (OGSP).
- Acceptable hematology within two months prior to the study, 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 the study, which includes pH, blood, glucose and protein.
- Signed the written informed consent to participate in this study.
Exclusion
- 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 one month prior to Period I (or Period III or Period V) 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 Period I (or Period III or Period V) dosing.
- Taking any prescription medication or any nonprescription medication within two weeks prior to Period I (or Period III or Period V) doing.
- Donating greater than 150 ml of blood within two months prior to Period I (or Period III or Period V) dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I (or Period III or Period V) 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, IUD, barrier device or abstinence) throughout the study.
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03451487
Start Date
May 19 2022
End Date
December 31 2022
Last Update
July 18 2023
Active Locations (1)
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1
Tri-Service General Hospital
Taipei, Neihu District, Taiwan, 114202