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Tolerability and Multiple-Dose Pharmacokinetics of Acetaminophen (Paracetamol) At and Above the Currently Recommended Maximum Daily Dose

Tolerability and Multiple-Dose Pharmacokinetics of Acetaminophen (Paracetamol) At and Above the Currently Recommended Maximum Daily Dose


CSR Summary

Not Yet Available


NCT Number

Not Available


Data Specification

Available upon data request approval


Annotated CRF

Available upon data request approval

Product Info

Generic Name
Acetaminophen
Product Name
TYLENOL®
Therapeutic Area
Pain, Inflammation, Fever
Enrollment
40
% Female
50.0%
% White
100.0%
Product Class
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Sponsor Protocol Number
02-161
Data Partner
Johnson & Johnson
Condition Studied
Healthy Volunteers
Mean/Median Age (Years)
25.3

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
1

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.