Healthy Volunteer Study Clinical Trial
Official title:
A Single-dose, Randomised, Crossover Study to Compare the Pharmacokinetics of Three Formulations of Ibuprofen in Healthy Fasting Male and Female Subjects
This is an open-label, randomised, 3-period, 3-sequence single-dose crossover study to
determine the comparative pharmacokinetic profile of the Test Investigational Medicinal
Product (IMP) Ibuprofen 200 mg soft gel capsule (lipid formulation) with that from the
reference products Nurofen® 200 mg tablet and ibuprofen 200 mg soft gel capsule following
single dose administration in healthy male and female subjects.
The study comprises of a pre-study screen (within 14 days of the first dose), followed by 3
Treatment Periods (1, 2 and 3) and a post study follow up (3 - 7 days after the last dose).
Each Treatment Period is of 1 day in duration, from the afternoon before dosing (Day -1)
until 12 hours (h) post-dose (Evening of Day 1). Study drug is administered on the morning
of Day 1 following an overnight fast. PK samples will be collected pre-dose and up to 12 h
post-dose (x15 samples) for the measurement of ibuprofen. Safety is evaluated at specified
times throughout the study. There is at least 48 h between dose administrations.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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