Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions (NCT06600282) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions
Taiwan14 participantsStarted 2024-10-01
Plain-language summary
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of parecoxib after intravenous bolus of parecoxib in healthy volunteers under fasting conditions
Who can participate
Age range20 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
✓. 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.
What they're measuring
1
Peak plasma concentration (Cmax)
Timeframe: 0 (pre-dose), 2, 5, 10, 20, 30, 40, 50 mins, and 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, 24, and 36 hours post dose (a total of 19 samples per subject in one period)
2
Area under the concentration-time curve from time zero to time of last quantifiable
Timeframe: 0 (pre-dose), 2, 5, 10, 20, 30, 40, 50 mins, and 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, 24, and 36 hours post dose (a total of 19 samples per subject in one period)
3
Area under the concentration-time curve from time zero to infinity (AUC 0-∞)
Timeframe: 0 (pre-dose), 2, 5, 10, 20, 30, 40, 50 mins, and 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, 24, and 36 hours post dose (a total of 19 samples per subject in one period)
✕. 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.