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

NCT04214691 | Completed Phase 1

• 2 other identifiers: CR108738RWJ3465PAI1002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Analyte Concentration (Cmax)

  Cmax is the maximum observed analyte concentration.

  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).

  Up to 24 hours post-dose

Secondary Outcomes (7)

• Area Under the Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity])

  Up to 24 hours post-dose

• Percentage of Area Under the Concentration-time Curve Extrapolated from Last Measurable Concentration to Infinite Time (extrapolated %AUCinfinity)

  Up to 24 hours post-dose

• Time to Reach the Maximum Observed Analyte Concentration (Tmax)

  Up to 24 hours post-dose

• Time to Last Measurable Plasma Concentration (T [last])

  Up to 24 hours post-dose

• Elimination Rate Constant (Lambda [z])

  Up to 24 hours post-dose

Study Arms (2)

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.

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 8H ER acetaminophen tablet orally in period 2 (Reference). Each period will be separated by a washout period of at least 7 days.

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

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

Also known as: Tylenol

Treatment Sequence 1: Reference Drug + Test Drug (RT); Treatment Sequence 2: Test Drug + Reference Drug (TR)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (1)

H plus Yangji Hospital

Seoul, 8779, South Korea

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

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

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: December 17, 2019
• Primary Completion: January 16, 2020
• Study Completion: February 7, 2020
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)