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Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions | Clinical Trials | Clareo Health

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

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

NCT06600282•Yung Shin Pharm. Ind. Co., Ltd.

View on ClinicalTrials.gov

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

Age

20 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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.
+7 more criteria

Locations (1)

Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

Key Dates

Start Date

October 1, 2024

Primary Completion Date

November 30, 2024

Completion Date

December 30, 2024

Last Updated

September 20, 2024

Enrollment

ESTIMATED participants

Conditions

Post-operative PainBioequivalence Study in Healthy Subjects

Interventions

Parecoxib

DRUG

Contacts

Chao-Kai Chang

CONTACT

TWN: 886-4-26875100 u51223@yungshingroup.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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