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

NCT ID: NCT06600282

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2024-12-30

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

Conditions

Post-operative Pain; Bioequivalence Study in Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Reference Drug

Active Ingredient: Parecoxib Dosage Form: Lyophilized powder for injection Strength: 40 mg/vial Dose: 40 mg (single intravenous bolus)

Group Type: ACTIVE_COMPARATOR

Parecoxib

Intervention Type: DRUG

Pharmacokinetic study under fasting conditions

Test Drug

Active Ingredient: Parecoxib Dosage Form: Lyophilized powder for injection Strength: 40 mg/vial Dose: 40 mg (single intravenous bolus)

Group Type: EXPERIMENTAL

Parecoxib

Intervention Type: DRUG

Pharmacokinetic study under fasting conditions

Interventions

Parecoxib

Pharmacokinetic study under fasting conditions

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yung Shin Pharm. Ind. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

Countries

Taiwan

Central Contacts

Chao-Kai Chang

Role: CONTACT

u51223@yungshingroup.com

TWN: 886-4-26875100 ext. 581

Facility Contacts

Kun-Hui Chen, M.D., Ph.D.

Role: primary

khc@vghtc.gov.tw

+886-4-2359-2525 ext. 6094

Other Identifiers

YSP-RQH3001-01

Identifier Type: -

Identifier Source: org_study_id