CompletedNot Applicable

A Randomized, Single-blind, Parallel Group and Multiple - Dose Design Study

Taiwan28 participantsStarted 2022-05-19

Plain-language summary

To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers.

Age range20 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. 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.

Percentage change from baseline of ALT peak level within study periods

Timeframe: Blood samples were collected on days 2-7 (before dosing)

NCT IDNCT03451487

SponsorSinew Pharma Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-31

Who can participate

Age range20 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. 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.