Study Comparing the Efficacy of Two Ibuprofen Formulations

• Pain Intensity Difference (PID) Scores at Each Individual Time Points [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.
• Pain Relief (PR) Scores at Individual Time Points [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  Response to the question "How much pain do you have from your starting pain?" was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken.
• Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ] [ Designated as safety issue: No ]
  SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).
• Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).
• Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ] [ Designated as safety issue: No ]
  SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).
• Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours [ Time Frame: 0-2 and 0-6 hours ] [ Designated as safety issue: No ]
  TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)
• Time to First Perceptible Relief [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.

This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.

• Drug: placebo
  2 placebo gels capsules delivered as a single dose.
• Drug: ibuprofen Formulation 1
  2 marketed ibuprofen gels
• Drug: ibuprofen Formulation 2
  2 marketed ibuprofen gels

• Placebo Comparator: 1
  Intervention: Drug: placebo
• Active Comparator: 2
  Intervention: Drug: ibuprofen Formulation 1
• Active Comparator: 3
  Intervention: Drug: ibuprofen Formulation 2

Inclusion criteria :

• Outpatients with post-operative pain following surgical extraction of third molars,
• examined by the attending dentist or physician and medically cleared to participate in the study,
• in general good health and have no contraindications to the study or rescue medication.

Exclusions criteria:

• any serious medical condition,
• acute localized dental infection at the time of surgery ,
• females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.