A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Acetaminophen
Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.
Other Names:
|
| Experimental: 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. |
Drug: Acetaminophen
Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Analyte Concentration (Cmax) [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]) [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).
Secondary Outcome Measures
- Area Under the Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity]) [Up to 24 hours post-dose]
AUC(0-infinity) is the area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z).
- Percentage of Area Under the Concentration-time Curve Extrapolated from Last Measurable Concentration to Infinite Time (extrapolated %AUCinfinity) [Up to 24 hours post-dose]
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.
- Time to Reach the Maximum Observed Analyte Concentration (Tmax) [Up to 24 hours post-dose]
Tmax is the time to reach the maximum observed analyte plasma concentration.
- Time to Last Measurable Plasma Concentration (T [last]) [Up to 24 hours post-dose]
Tlast is the time to last measurable plasma concentration.
- Elimination Rate Constant (Lambda [z]) [Up to 24 hours post-dose]
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.
- Elimination Half-Life (t 1/2) [Up to 24 hours post-dose]
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).
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [Up to 41 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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
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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
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Have no history of psychiatric disorder within the 5 years prior to the screening
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Have no history of gastrointestinal resection that may affect drug absorption
Exclusion Criteria:
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Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening as deemed appropriate by the investigator
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Known allergies, hypersensitivity, or intolerance to acetaminophen or its excipients
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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)
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Taken any disallowed therapies as noted in local prescribing information, concomitant therapy before the planned first dose of study drug
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Use of any prescription or nonprescription medication (including oriental medicines) within 30 days before the first dose of the study drug is scheduled
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | H plus Yangji Hospital | Seoul | Korea, Republic of | 8779 |
Sponsors and Collaborators
- Janssen Korea, Ltd., Korea
Investigators
- Study Director: Janssen Korea, Ltd., Korea Clinical Trial, Janssen Korea, Ltd., Korea
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108738
- RWJ3465PAI1002