HealthyPhase 1NCT04230252
A Study of the Newly Formulated Tylenol Tablet (Acetaminophen) to the Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants
A Phase 1 study testing Acetaminophen in people with Healthy, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 mg) with respect to the Tylenol 8 Hour (H) Extended Release (ER) tablet (acetaminophen 650 mg) in healthy participants under fasting conditions. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2020to 23 Mar 2020
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, urinalysis or breathing alcohol test are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
- Have no history of psychiatric disorder within the 5 years prior to the screening
- Have no history of gastrointestinal resection that may affect drug absorption
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 60 milliliter per minute [mL/min]), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening as deemed appropriate by the investigator
- Known allergies, hypersensitivity, or intolerance to acetaminophen or its excipients
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Taken any disallowed therapies as noted in local prescribing information, concomitant therapy before the planned first dose of study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Open-label, Randomized, Two-treatment, Two-period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of the Newly Formulated Tylenol® Tablet (Acetaminophen) to the Tylenol® 8H ER Tablet (Acetaminophen) Under Fasting Conditions
The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 mg) with respect to the Tylenol 8 Hour (H) Extended Release (ER) tablet (acetaminophen 650 mg) in healthy participants under fasting conditions.
- Conditions
- Healthy
- Being tested
- Acetaminophen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol, JNJ-28678-AAA
Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1: Reference Drug + Test Drug (RT) | Experimental | Participants will receive 8 hour (H) extended-release (ER) acetaminophen tablet orally in period 1 (Reference) followed by newly formulated acetaminophen tablet orally in period 2 (Test). Each period will be separated by a washout period of at least 7 days. Receives: Drug: Acetaminophen |
| Treatment Sequence 2: Test Drug + Reference Drug (TR) | Experimental | Participants will receive newly formulated acetaminophen tablet orally in period 1 (Test) followed by 8 hour ER acetaminophen tablet orally in period 2 (Reference). Each period will be separated by a washout period of at least 7 days. Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Analyte Concentration (Cmax)
Cmax is the maximum observed analyte concentration.
Measured: Up to 24 hours post-dose
Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUC [0-last])
AUC (0-last) is the area under the concentration-time curve from time 0 to time of the last measurable concentration (non-below quantitation limit).
Measured: Up to 24 hours post-dose
Secondary outcomes (7)
Area Under the Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity])
AUC(0-infinity) is the area under the concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z).
Measured: Up to 24 hours post-dose
Percentage of Area Under the Concentration-time Curve Extrapolated from Last Measurable Concentration to Infinite Time (Extrapolated %AUCinfinity)
Percentage of area under the concentration-time curve extrapolated from last measurable concentration to infinite time (extrapolated %AUCinfinity) is calculated using formula: (AUC [0-infinity] minus AUC [0-last]/AUC [0-infinity])*100.
Measured: Up to 24 hours post-dose
Time to Reach the Maximum Observed Analyte Concentration (Tmax)
Tmax is the time to reach the maximum observed analyte concentration.
Measured: Up to 24 hours post-dose
Time to Last Measurable Plasma Concentration (T [last])
Tlast is the time to last measurable plasma concentration.
Measured: Up to 24 hours post-dose
Elimination Rate Constant (Lambda [z])
Lambda (z) is the apparent terminal elimination rate constant determined by linear regression using the terminal log-linear phase of the log transformed concentration-time curve.
Measured: Up to 24 hours post-dose
Elimination Half-Life (t 1/2)
t1/2 is defined as apparent is associated terminal elimination half-life associated with the terminal slope (lambda [z]) of the semilogarithmic drug concentration-time curve, calculated as: 0.693/lambda(z).
Measured: Up to 24 hours post-dose
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: Up to 41 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start7 Jan 2020
- Primary completion10 Feb 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230252
- Sponsor's protocol ID
- CR108737
- Other IDs
- RWJ3465PAI1001, DDS19-028BE
- Status last verified
- Apr 2025
- First submitted
- 14 Jan 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Open-label, Randomized, Two-treatment, Two-period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of the Newly Formulated Tylenol® Tablet (Acetaminophen) to the Tylenol® 8H ER Tablet (Acetaminophen) Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04230252
- Acronym / sponsor ID
- CR108737
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 18 Jan 2020 (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.
The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 mg) with respect to the Tylenol 8 Hour (H) Extended Release (ER) tablet (acetaminophen 650 mg) in healthy participants under fasting conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1: Reference Drug + Test Drug (RT) | Experimental | Drug: AcetaminophenParticipants will receive 8 hour (H) extended-release (ER) acetaminophen tablet orally in period 1 (Reference) followed by newly formulated acetaminophen tablet orally in period 2 (Test). Each period will be separated by a washout period of at least 7 days. |
| Treatment Sequence 2: Test Drug + Reference Drug (TR) | Experimental | Drug: AcetaminophenParticipants will receive newly formulated acetaminophen tablet orally in period 1 (Test) followed by 8 hour ER acetaminophen tablet orally in period 2 (Reference). Each period will be separated by a washout period of at least 7 days. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents
- Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, urinalysis or breathing alcohol test are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
- Have no history of psychiatric disorder within the 5 years prior to the screening
- Have no history of gastrointestinal resection that may affect drug absorption
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 60 milliliter per minute [mL/min]), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening as deemed appropriate by the investigator
- Known allergies, hypersensitivity, or intolerance to acetaminophen or its excipients
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Taken any disallowed therapies as noted in local prescribing information, concomitant therapy before the planned first dose of study drug
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 |
|---|---|---|
| AcetaminophenAlso: Tylenol, JNJ-28678-AAAAcetaminophen tablet will be administered orally in treatment sequence 1 and 2. | Drug | Treatment Sequence 1: Reference Drug + Test Drug (RT), Treatment Sequence 2: Test Drug + Reference Drug (TR) |
Primary outcome
Maximum Observed Analyte Concentration (Cmax)
Time frame: Up to 24 hours post-dose
Cmax is the maximum observed analyte concentration.
Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUC [0-last])
Time frame: Up to 24 hours post-dose
AUC (0-last) is the area under the concentration-time curve from time 0 to time of the last measurable concentration (non-below quantitation limit).
7 secondary outcomes
Area Under the Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity])
Time frame: Up to 24 hours post-dose
Percentage of Area Under the Concentration-time Curve Extrapolated from Last Measurable Concentration to Infinite Time (Extrapolated %AUCinfinity)
Time frame: Up to 24 hours post-dose
Time to Reach the Maximum Observed Analyte Concentration (Tmax)
Time frame: Up to 24 hours post-dose
Time to Last Measurable Plasma Concentration (T [last])
Time frame: Up to 24 hours post-dose
Elimination Rate Constant (Lambda [z])
Time frame: Up to 24 hours post-dose
Elimination Half-Life (t 1/2)
Time frame: Up to 24 hours post-dose
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 41 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acetaminophen in people with Healthy, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 27 Apr 2025. 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 South Korea. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Analyte Concentration (Cmax) (time frame: Up to 24 hours post-dose). The study lists 2 primary outcomes in all. 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 Apr 2025.