HepatitisNCT05563961
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
A study testing Panadol® and SafeTynadol® in people with Hepatitis and Pharmacology, run by Sinew Pharma Inc. at 1 site in Taiwan.
Trial summary
To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers and the safety in SafeTynadol® dose-limiting hepatotoxicity. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis, Pharmacology
- What is being tested?
- Panadol® and SafeTynadol®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Oct 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, Neihu District, 114202
ChengHuei Mr. Hsiong, Vice President, +886-2-2788-5365, info@sinewpharma.com
PoKuan Mr. Chao, Research, +886-2-2788-5365, paikuan.chao@sinewpharma.com
About this study
To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers and the safety in SafeTynadol® dose-limiting hepatotoxicity.
Read the detailed description
Subjects will be randomized to Cohort 1 and cohort 2 in the study without crossover, Cohort 3-8 will be a dose-escalation manner. An effort will be made to balance the number of males and females in each cohort.
The first treatment cohort 1 and 2 will enroll 12 study volunteers. The volunteers of cohort 1 will receive Panadol® oral dosage form is 500 mg*2 tablets = 1,000 mg/ person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 8 tablets, 4,000 mg) (n = 6) and cohort 2 will receive SafeTynadol® oral dosage form is 500 mg*2 tablets = 1,000 mg/ person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 8 tablets, 4,000 mg) (n = 6) in an single-blind, randomized manner.
About one to three weeks later, cohorts 3-8 will be studied in an order of increasing dose of SafeTynadol® starting from 4,500 mg increment to a maximum dose of 12,000 mg of SafeTynadol® if the previous cohort do not meet the significant criteria of hepatotoxicity.
Cohort 3-8 will initially enroll 3 study volunteers. Volunteers will receive SafeTynadol® oral dosage form is 500 mg*3 tablets at first dosage (1500 mg) and 500 mg every 6 hours *2 tablets at second to fourth dosage (1000 mg) person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 9 tablets, 4,500 mg) at cohort 3 or Volunteers will receive SafeTynadol® oral dosage form is 500 mg*3 tablets at first and second dosage (1500 mg) and 500 mg every 6 hours *2 tablets at third and fourth dosage (1000 mg) person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 10 tablets, 5,000 mg) at cohort 4 or Volunteers will receive SafeTynadol® oral dosage form is 500 mg*3 tablets = 1,500 mg/ person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 12 tablets, 6,000 mg) at cohort 5 or Volunteers will receive SafeTynadol® oral dosage form is 500 mg*4 tablets = 2,000 mg/ person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 16 tablets, 8,000 mg) at cohort 6 or Volunteers will receive multiple doses of SafeTynadol® oral dosage form 500 mg every 6 hours * 5 tablets = 2,500 mg/person every 6 hours daily of the multiple-dose treatment (Q6H, 4 doses, 20 tablets, 10,000 mg) at Cohort 7 or Volunteers will receive multiple doses of SafeTynadol® oral dosage form 500 mg every 6 hours * 6 tablets = 3,000 mg/person every 6 hours daily of the multiple-dose treatment (Q6H, 4 doses, 24 tablets, 12,000 mg) at Cohort 8.
In Cohort 3-8, liver function tests will be administered two hours after the third dose to confirm that the hepatotoxicity criteria are not met before the fourth dose can be administered and Cohort 6-8 will perform liver function tests two hours after the second dose administered to confirm that the hepatotoxicity criteria are not met before the third dose can be administered. After 3 study volunteers to confirm that did not meet significant hepatotoxicity occurs then another 3 study volunteers were included, study will in a dose-escalation manner.
Except at admission blood blank sampling to Clinical Research Center on day 1 at 10:00, sampling will be obtained at the following times last post dose: 0 (prior to the last dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours after administration (21 samples) to assess acetaminophen concentrations and its metabolites concentrations. In addition, Cohort 1-8 blood sample for liver function test (ALT, AST, total bilirubinl) and PT(INR) will be obtained on day 1 (10:00) after admission, two hours after the third dose on day 2 and 24, 48, 72, 96, 120 and 144 hours after the last dose, Cohort 6-8 will increase the assessment of liver function tests two hours after the second dose. Blood samples for blood chemistry, PT(INR), hematology (CBC) and OGSP will be collected on 168 hours for post-study evaluation.
- Conditions
- Hepatitis, Pharmacology
- Being tested
- Panadol®, SafeTynadol®
- Keywords
- acetaminophen, acute liver failure
- Medical subject headings
- Hepatitis, Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panadol®Drug
Reference Drug. Multiple-dose stage: Cohort 1, 2 tablets Q6H (total 4 dosages, 8 tablets or 4,000 mg)
SafeTynadol®Drug
Test Drugs. Multiple-dose stage:
Cohort 2, 2 tablets Q6H (total 4 dosages, 8 tablets or 4,000 mg) Cohort 3, 3 tablets at first dosage and 2 tablets at second to forth dosage Q6H (total 4 dosages, 9 tablets or 4,500 mg) Cohort 4, 3 tablets at first to second dosage and 2 tablets at third to forth dosage Q6H (total 4 dosages, 10 tablets or 5,000 mg) Cohort 5, 3 tablets Q6H (total 4 dosages, 12 tablets or 6,000 mg) Cohort 6, 4 tablets Q6H (total 4 dosages, 16 tablets or 8,000 mg) Cohort 7, 5 tablets Q6H (total 4 dosages, 20 tablets or 10,000 mg) Cohort 8, 6 tablets Q6H (total 4 dosages, 24 tablets or 12,000 mg)
| Study group | Role | What they receive |
|---|---|---|
| Panadol | Active comparator | • Cohort 1- 6 Subjects to receive oral Panadol® 4,000 mg (2 tablets Q6H, 4 dosages, 8 tablets or 4,000 mg) Receives: Drug: Panadol® |
| SafeTynadol® | Experimental | * Cohort 2- 6 Subjects to receive oral SafeTynadol® 4,000 mg (2 tablets Q6H, 4 dosages, 8 tablets or 4,000 mg)
* Cohort 3- 6 Subjects to receive oral SafeTynadol® 4,500 mg (3 tablets at first dosage and 2 tablets at second to forth dosage Q6H, 4 dosages, 9 tablets or 4,500 mg)
* Cohort 4- 6 Subjects to receive oral SafeTynadol® 5,000 mg (3 tablets at first to second dosage and 2 tablets at third to forth dosage Q6H, 4 dosages, 10 tablets or 5,000 mg)
* Cohort 5- 6 Subjects to receive oral SafeTynadol® 6,000 mg (3 tablets Q6H, 4 dosages, 12 tablets or 6,000 mg)
* Cohort 6- 6 Subjects to receive oral SafeTynadol® 8,000 mg (4 tablets Q6H, 4 dosages, 16 tablets or 8,000 mg)
* Cohort 7- 6 Subjects to receive oral SafeTynadol® 10,000 mg (5 tablets Q6H, 4 dosages, 20 tablets or 10,000 mg)
* Cohort 8- 6 Subjects to receive oral SafeTynadol® 12,000 mg (6 tablets Q6H, 4 dosages, 24 tablets or 12,000 mg) Receives: Drug: SafeTynadol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALT level within study periods
Measured: Day 1-9
Secondary outcomes (10)
Incidence of peak ALT elevations > 1X ULN within study periods
Measured: Day 1-9
Incidence of peak ALT elevations > 2X ULN within study periods
Measured: Day 1-9
Incidence of peak ALT elevations > 3X ULN within study periods
Measured: Day 1-9
Incidence of peak ALT elevations > 5X ULN within study periods
Measured: Day 1-9
Incidence of peak ALT elevations > 8X ULN within study periods
Measured: Day 1-9
Incidence of total bilirubin > 2.5mg/dL within study periods
Measured: Day 1-9
Incidence of PT (INR) > 1.25 within study periods
Measured: Day 1-9
Hepatic failure rate
Hepatic failure rate (hepatic encephalopathy, ascites, total bilirubin >2.5mg/dL, PT(INR) >1.25 , or liver transplantation) within study periods
Measured: Day 1-9
Free plasma acetaminophen-cysteine (AAP-Cys) and AAP-Cys adducts
The time-interval weighted area under the curve (AUC) of free plasma acetaminophen-cysteine (AAP-Cys) and AAP-Cys adducts within study periods
Measured: Day 1-9
The time-interval weighted area under the curve (AUC) of ALT level within study periods
Measured: Day 1-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start28 Oct 2022
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinew Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563961
- Sponsor's protocol ID
- Oral AAP-002
- Status last verified
- Feb 2024
- First submitted
- 27 Sep 2022
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05563961
- Acronym / sponsor ID
- Oral AAP-002
- Conditions
- Hepatitis, Pharmacology
- Keywords
- acetaminophen, acute liver failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sinew Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers and the safety in SafeTynadol® dose-limiting hepatotoxicity.
Detailed description
Subjects will be randomized to Cohort 1 and cohort 2 in the study without crossover, Cohort 3-8 will be a dose-escalation manner. An effort will be made to balance the number of males and females in each cohort.
The first treatment cohort 1 and 2 will enroll 12 study volunteers. The volunteers of cohort 1 will receive Panadol® oral dosage form is 500 mg*2 tablets = 1,000 mg/ person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 8 tablets, 4,000 mg) (n = 6) and cohort 2 will receive SafeTynadol® oral dosage form is 500 mg*2 tablets = 1,000 mg/ person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 8 tablets, 4,000 mg) (n = 6) in an single-blind, randomized manner.
About one to three weeks later, cohorts 3-8 will be studied in an order of increasing dose of SafeTynadol® starting from 4,500 mg increment to a maximum dose of 12,000 mg of SafeTynadol® if the previous cohort do not meet the significant criteria of hepatotoxicity.
Cohort 3-8 will initially enroll 3 study volunteers. Volunteers will receive SafeTynadol® oral dosage form is 500 mg*3 tablets at first dosage (1500 mg) and 500 mg every 6 hours *2 tablets at second to fourth dosage (1000 mg) person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 9 tablets, 4,500 mg) at cohort 3 or Volunteers will receive SafeTynadol® oral dosage form is 500 mg*3 tablets at first and second dosage (1500 mg) and 500 mg every 6 hours *2 tablets at third and fourth dosage (1000 mg) person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 10 tablets, 5,000 mg) at cohort 4 or Volunteers will receive SafeTynadol® oral dosage form is 500 mg*3 tablets = 1,500 mg/ person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 12 tablets, 6,000 mg) at cohort 5 or Volunteers will receive SafeTynadol® oral dosage form is 500 mg*4 tablets = 2,000 mg/ person every 6 hours daily of the multiple-dose treatment (Q6H, total 4 dosages, 16 tablets, 8,000 mg) at cohort 6 or Volunteers will receive multiple doses of SafeTynadol® oral dosage form 500 mg every 6 hours * 5 tablets = 2,500 mg/person every 6 hours daily of the multiple-dose treatment (Q6H, 4 doses, 20 tablets, 10,000 mg) at Cohort 7 or Volunteers will receive multiple doses of SafeTynadol® oral dosage form 500 mg every 6 hours * 6 tablets = 3,000 mg/person every 6 hours daily of the multiple-dose treatment (Q6H, 4 doses, 24 tablets, 12,000 mg) at Cohort 8.
In Cohort 3-8, liver function tests will be administered two hours after the third dose to confirm that the hepatotoxicity criteria are not met before the fourth dose can be administered and Cohort 6-8 will perform liver function tests two hours after the second dose administered to confirm that the hepatotoxicity criteria are not met before the third dose can be administered. After 3 study volunteers to confirm that did not meet significant hepatotoxicity occurs then another 3 study volunteers were included, study will in a dose-escalation manner.
Except at admission blood blank sampling to Clinical Research Center on day 1 at 10:00, sampling will be obtained at the following times last post dose: 0 (prior to the last dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours after administration (21 samples) to assess acetaminophen concentrations and its metabolites concentrations. In addition, Cohort 1-8 blood sample for liver function test (ALT, AST, total bilirubinl) and PT(INR) will be obtained on day 1 (10:00) after admission, two hours after the third dose on day 2 and 24, 48, 72, 96, 120 and 144 hours after the last dose, Cohort 6-8 will increase the assessment of liver function tests two hours after the second dose. Blood samples for blood chemistry, PT(INR), hematology (CBC) and OGSP will be collected on 168 hours for post-study evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panadol | Active comparator | Drug: Panadol®• Cohort 1- 6 Subjects to receive oral Panadol® 4,000 mg (2 tablets Q6H, 4 dosages, 8 tablets or 4,000 mg) |
| SafeTynadol® | Experimental | Drug: SafeTynadol®* Cohort 2- 6 Subjects to receive oral SafeTynadol® 4,000 mg (2 tablets Q6H, 4 dosages, 8 tablets or 4,000 mg) * Cohort 3- 6 Subjects to receive oral SafeTynadol® 4,500 mg (3 tablets at first dosage and 2 tablets at second to forth dosage Q6H, 4 dosages, 9 tablets or 4,500 mg) * Cohort 4- 6 Subjects to receive oral SafeTynadol® 5,000 mg (3 tablets at first to second dosage and 2 tablets at third to forth dosage Q6H, 4 dosages, 10 tablets or 5,000 mg) * Cohort 5- 6 Subjects to receive oral SafeTynadol® 6,000 mg (3 tablets Q6H, 4 dosages, 12 tablets or 6,000 mg) * Cohort 6- 6 Subjects to receive oral SafeTynadol® 8,000 mg (4 tablets Q6H, 4 dosages, 16 tablets or 8,000 mg) * Cohort 7- 6 Subjects to receive oral SafeTynadol® 10,000 mg (5 tablets Q6H, 4 dosages, 20 tablets or 10,000 mg) * Cohort 8- 6 Subjects to receive oral SafeTynadol® 12,000 mg (6 tablets Q6H, 4 dosages, 24 tablets or 12,000 mg) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Normal healthy adult subjects between 20-50 years of age.
- Body weight within 80-120% of ideal body weight.
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panadol®Reference Drug. Multiple-dose stage: Cohort 1, 2 tablets Q6H (total 4 dosages, 8 tablets or 4,000 mg) | Drug | Panadol |
| SafeTynadol®Test Drugs. Multiple-dose stage: Cohort 2, 2 tablets Q6H (total 4 dosages, 8 tablets or 4,000 mg) Cohort 3, 3 tablets at first dosage and 2 tablets at second to forth dosage Q6H (total 4 dosages, 9 tablets or 4,500 mg) Cohort 4, 3 tablets at first to second dosage and 2 tablets at third to forth dosage Q6H (total 4 dosages, 10 tablets or 5,000 mg) Cohort 5, 3 tablets Q6H (total 4 dosages, 12 tablets or 6,000 mg) Cohort 6, 4 tablets Q6H (total 4 dosages, 16 tablets or 8,000 mg) Cohort 7, 5 tablets Q6H (total 4 dosages, 20 tablets or 10,000 mg) Cohort 8, 6 tablets Q6H (total 4 dosages, 24 tablets or 12,000 mg) | Drug | SafeTynadol® |
Primary outcome
ALT level within study periods
Time frame: Day 1-9
10 secondary outcomes
Incidence of peak ALT elevations > 1X ULN within study periods
Time frame: Day 1-9
Incidence of peak ALT elevations > 2X ULN within study periods
Time frame: Day 1-9
Incidence of peak ALT elevations > 3X ULN within study periods
Time frame: Day 1-9
Incidence of peak ALT elevations > 5X ULN within study periods
Time frame: Day 1-9
Incidence of peak ALT elevations > 8X ULN within study periods
Time frame: Day 1-9
Incidence of total bilirubin > 2.5mg/dL within study periods
Time frame: Day 1-9
Incidence of PT (INR) > 1.25 within study periods
Time frame: Day 1-9
Hepatic failure rate
Time frame: Day 1-9
Free plasma acetaminophen-cysteine (AAP-Cys) and AAP-Cys adducts
Time frame: Day 1-9
The time-interval weighted area under the curve (AUC) of ALT level within study periods
Time frame: Day 1-9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panadol® and SafeTynadol® in people with Hepatitis and Pharmacology, run by Sinew Pharma Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ChengHuei Mr. Hsiong, Vice President (+886-2-2788-5365, info@sinewpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALT level within study periods (time frame: Day 1-9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024; AzTrials last refreshed its copy on 27 Oct 2026.