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

Inclusion criteria

• Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.
• Body mass index (BMI) between 18 and 27 kg/m2 (not inclusive) at the screening visit.
• Acceptable medical history and physical examination including:

• no particular clinically significant abnormalities in Electrocardiogram (ECG) results within six months prior to Period I dosing.
• no particular clinical significance in general disease history within two months prior to Period I dosing.
• Acceptable biochemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes Alanine aminoTransferase (ALT), Aspartate aminoTransferase (AST), gamma-GT, alkaline phosphatase, total bilirubin, albumin, glucose, Blood urea nitrogen (BUN), uric acid, creatinine, total cholesterol, and triglyceride (TG).
• Acceptable hematology (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials, and platelets.
• Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes pH, blood, glucose, ketones, bilirubin, and protein.
• Subjects must use an acceptable method of birth control (e.g. abstinence, condom, intrauterine device, and vasectomy) for the duration of the study.
• Have signed the written informed consent to participate in the study.

Exclusion criteria

• A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, urinary tract, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease.
• A clinically significant illness or surgery within four weeks prior to Period I dosing.
• 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.
• History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
• Known or suspected history of drug abuse within lifetime.
• History of alcohol addiction or abuse within last five years.
• History of allergic response(s) to parecoxib, valdecoxib or any other related drugs.
• Evidence of chronic or acute infectious diseases.
• Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
• Female subjects demonstrating a positive pregnancy screen.
• Female subjects who are currently breastfeeding.
• 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.
• 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.
• Use of any investigational drug (excluding COVID-19 vaccination) within four weeks prior to Period I dosing.
• Use of any COVID-19 vaccine within seven days prior to Period I dosing.
• 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.
• Any other medical reason as determined by the investigator.