Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction

National, Multicentre, Randomized, Double-blind, Triple-dummy Active-Controled Phase III Clinical Trial to Evaluate the Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction.

The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.

Main Inclusion Criteria:

• Males and Females aged 18 to 40 years;
• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
• Participants who require extraction of impacted mandibular third molar.

Main Exclusion Criteria:

• Known hypersensitivity to the formula components used during the clinical trial;
• Previous history of alcohol or drugs abuse diagnosed by DSM-V;
• Previous history of renal failure from moderate to severe;
• Women who are pregnant, lactating, or positive for β - hCG urine test.