Muscle Soreness Clinical Trial
Official title:
A DOUBLE-BLIND, REPEAT-DOSE, PARALLEL GROUP, PILOT STUDY COMPARING THE EFFICACY AND SAFETY OF ORALLY ADMINISTERED IBUPROFEN AND PLACEBO IN DELAYED ONSET MUSCLE SORENESS
The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing the safety and efficacy of oral ibuprofen to placebo over 24 hours.
This is a double-blind, randomized, placebo controlled, parallel group, pilot safety and
efficacy study. Healthy male or female subjects who have a history of occasional muscle
soreness and are not currently exercising will be asked to volunteer for the study. All
subjects will complete an informed consent process prior to study procedures.
The study duration is anticipated to be approximately 4 months. Each subject may be in the
study for up to 45 days including screening, run-in, inpatient and outpatient dosing and
assessments, follow-up visit and follow-up telephone contact.
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