Clinical trial NCT04214691: A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants
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 Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2020-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 milligram \[mg\]) with respect to the Tylenol 8 hour (H) extended-release (ER) tablet (acetaminophen 650 mg) in healthy participants under fed conditions.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Use of any prescription or nonprescription medication (including oriental medicines) within 30 days before the first dose of the study drug is scheduled

Primary outcomes:
measure: Maximum Observed Analyte Concentration (Cmax)
timeFrame: Up to 24 hours post-dose
measure: Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUC [0-last])
timeFrame: Up to 24 hours post-dose
Secondary outcomes:
measure: Area Under the Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity])
timeFrame: Up to 24 hours post-dose
measure: Percentage of Area Under the Concentration-time Curve Extrapolated from Last Measurable Concentration to Infinite Time (extrapolated %AUCinfinity)
timeFrame: Up to 24 hours post-dose
measure: Time to Reach the Maximum Observed Analyte Concentration (Tmax)
timeFrame: Up to 24 hours post-dose
measure: Time to Last Measurable Plasma Concentration (T [last])
timeFrame: Up to 24 hours post-dose
measure: Elimination Rate Constant (Lambda [z])
timeFrame: Up to 24 hours post-dose
measure: Elimination Half-Life (t 1/2)
timeFrame: Up to 24 hours post-dose
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to 41 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H plus Yangji Hospital
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: