Status:
NOT_YET_RECRUITING
Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions
Lead Sponsor:
Yung Shin Pharm. Ind. Co., Ltd.
Conditions:
Post-operative Pain
Bioequivalence Study in Healthy Subjects
Eligibility:
All Genders
20-45 years
Phase:
PHASE4
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06600282
Start Date
October 1 2024
End Date
December 30 2024
Last Update
September 20 2024
Active Locations (1)
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1
Taichung Veterans General Hospital
Taichung, Taiwan, Taiwan, 40705