A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants

NCT ID: NCT04214691

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-17
• Study Completion Date: 2020-02-07

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment Sequence 1: Reference Drug + Test Drug (RT)

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.

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.

Treatment Sequence 2: Test Drug + Reference Drug (TR)

Participants will receive newly formulated acetaminophen tablet orally in period 1 (Test) followed by 8H ER acetaminophen tablet orally in period 2 (Reference). Each period will be separated by a washout period of at least 7 days.

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.

Interventions

Acetaminophen

Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.

Intervention Type: DRUG

Other Intervention Names

Tylenol

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Locations

H plus Yangji Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

RWJ3465PAI1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108738

Identifier Type: -

Identifier Source: org_study_id