Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions

Exclusion Criteria

• •1. A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, urinary tract, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease.
• •2. A clinically significant illness or surgery within four weeks prior to Period I dosing.
• •3. History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
• •4. History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
• •5. Known or suspected history of drug abuse within lifetime.
• •6. History of alcohol addiction or abuse within last five years.
• •7. History of allergic response(s) to parecoxib, valdecoxib or any other related drugs.
• •8. Evidence of chronic or acute infectious diseases.
• •9. Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
• •10. Female subjects demonstrating a positive pregnancy screen.
• •11. Female subjects who are currently breastfeeding.
• •12. Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to Period I dosing. Examples of inducers include: piperidines, carbamazepine, dexamethasone, and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone, and ranitidine.
• •13. Taking any prescription medications within four weeks or any nonprescription medications (excluding flu and COVID-19 vaccination) within two weeks prior to Period I dosing.
• •14. Use of any investigational drug (excluding COVID-19 vaccination) within four weeks prior to Period I dosing.
• •15. Use of any COVID-19 vaccine within seven days prior to Period I dosing.
• •16. Donating more than 250 mL of blood within two months prior to Period I dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I dosing.
• •17. Any other medical reason as determined by the investigator.