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

NCT03451487 | Completed

• 1 other identifier: Oral AAP-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acetaminophen Toxicity

Keywords

acetaminophen; acute liver failure

Outcome Measures

Primary Outcomes (1)

• Percentage change from baseline of ALT peak level within study periods

  ALT peak level in blood after administration

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

Secondary Outcomes (9)

• - Incidence of peak ALT elevations > 1X ULN within study periods;

  Day 1-7

• - Incidence of peak ALT elevations > 2X ULN within study periods;

  Day 1-7

• - Incidence of peak ALT elevations > 3X ULN within study periods;

  Day 1-7

• - Incidence of peak ALT elevations > 5X ULN within study periods;

  Day 1-7

• - Incidence of peak ALT elevations > 8X ULN within study periods;

  Day 1-7

Other Outcomes (10)

• - Incidence of adverse events

  Day 1-12

• - Clinical laboratory test

  Day 1-12

• - Clinical laboratory test

  Day 1-12

Study Arms (6)

Reference drug (1000mg)

PLACEBO COMPARATOR

Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period I and II. The study was completed when there were at least 12 evaluable subjects. Panadol® oral dosage form (500 mg\*2 tablets = 1000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study period.

Drug: Panadol®

Test drug (1000mg)

EXPERIMENTAL

Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period I and II. The study was completed when there were at least 12 evaluable subjects. SafeTynadol® oral dosage form (500 mg\*2 tablets = 1000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study period.

Drug: SafeTynadol®

Reference drug (4000mg)

PLACEBO COMPARATOR

Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period III and IV. The study was completed when there were at least 12 evaluable subjects. Panadol® oral dosage form (500 mg\*8 tablets = 4000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study period.

Drug: Panadol®

Test drug (4000mg)

EXPERIMENTAL

Eligible subjects were randomly assigned to either of the two treatment sequence.The evaluable subjects were those who had completed both period III and IV. The study was completed when there were at least 12 evaluable subjects. SafeTynadol® oral dosage form (500 mg\*8 tablets = 4000 mg) was orally administered with 240 ml of water once daily in the morning in each of the single-dose study

Drug: SafeTynadol®

Reference drug 2 tablets Q6H (28,000mg)

PLACEBO COMPARATOR

Eligible subjects were randomly assigned to either of the two treatment stage.Each treatment will be completed when there are at least 7 evaluable subjects. The evaluable subjects are randomized into period V. Panadol® oral dosage form (500mg\*2 tablets =1000mg) will be orally administered with 240 ml of water every 6 hours daily in each of the multiple-dose study period (Q6H, total 28 dosages, 56 tablets).

Drug: Panadol®

Test drug 2 tablets Q6H (28,000mg)

EXPERIMENTAL

Eligible subjects were randomly assigned to either of the two treatment stage.Each treatment will be completed when there are at least 7 evaluable subjects. The evaluable subjects are randomized into period V. SafeTynadol® oral dosage form (500mg\*2 tablets =1000mg) will be orally administered with 240 ml of water every 6 hours daily in each of the multiple-dose study period (Q6H, total 28 dosages, 56 tablets).

Drug: SafeTynadol®

Interventions

Panadol® DRUG

Acetaminophen 500mg Tablet

Also known as: Acetaminophen

Reference drug (1000mg); Reference drug (4000mg); Reference drug 2 tablets Q6H (28,000mg)

SafeTynadol® DRUG

Acetaminophen 500mg Tablet

Also known as: SNP-810

Test drug (1000mg); Test drug (4000mg); Test drug 2 tablets Q6H (28,000mg)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinew Pharma Inc.: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Neihu District, 114202, Taiwan

Location

MeSH Terms

Conditions

Liver Failure, Acute

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• TeYu Mr Lin, Dr.

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Blindie

Study Record Dates

• First Submitted: February 24, 2018
• First Posted: March 1, 2018
• Study Start: May 19, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-04

Locations

TW (1)