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

Phase 4

Not yet recruiting

• Conditions: Post-operative Pain; Bioequivalence Study in Healthy Subjects
• Interventions: Drug: Parecoxib

• Registration Number: NCT06600282
• Lead Sponsor: Yung Shin Pharm. Ind. Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.

2. Body mass index (BMI) between 18 and 27 kg/m2 (not inclusive) at the screening visit.

3. 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.

4. 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).

5. 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.

6. 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.

7. Subjects must use an acceptable method of birth control (e.g. abstinence, condom, intrauterine device, and vasectomy) for the duration of the study.

8. Have signed the written informed consent to participate in the study.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference Drug	Parecoxib	Active Ingredient: Parecoxib Dosage Form: Lyophilized powder for injection Strength: 40 mg/vial Dose: 40 mg (single intravenous bolus)
Test Drug	Parecoxib	Active Ingredient: Parecoxib Dosage Form: Lyophilized powder for injection Strength: 40 mg/vial Dose: 40 mg (single intravenous bolus)

Primary Outcome Measures

Name	Time	Method
Peak plasma concentration (Cmax)	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)
Area under the concentration-time curve from time zero to time of last quantifiable	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)
Area under the concentration-time curve from time zero to infinity (AUC 0-∞)	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)

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan