Post-operative PainPhase 4NCT06600282
Bioequivalence of Two Formulations of Parecoxib in Healthy Volunteers Under Fasting Conditions
A Phase 4 study testing Parecoxib in people with Post-operative Pain and Bioequivalence Study in Healthy Subjects, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Bioequivalence Study in Healthy Subjects
- What is being tested?
- Parecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2024to 30 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Kun-Hui Chen, M.D., Ph.D., +886-4-2359-2525 ext. 6094, khc@vghtc.gov.tw
About this study
Official title: 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
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
- Being tested
- Parecoxib
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParecoxibDrug
Pharmacokinetic study under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| Reference Drug | Active comparator | Active Ingredient: Parecoxib Dosage Form: Lyophilized powder for injection Strength: 40 mg/vial Dose: 40 mg (single intravenous bolus) Receives: Drug: Parecoxib |
| Test Drug | Experimental | Active Ingredient: Parecoxib Dosage Form: Lyophilized powder for injection Strength: 40 mg/vial Dose: 40 mg (single intravenous bolus) Receives: Drug: Parecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax)
Measured: 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
Measured: 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-∞)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An open-label, randomized, balanced, two-treatment, two-period, two-sequence, single dose, two-way crossover study under fasting conditions
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600282
- Sponsor's protocol ID
- YSP-RQH3001-01
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06600282
- Acronym / sponsor ID
- YSP-RQH3001-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, randomized, balanced, two-treatment, two-period, two-sequence, single dose, two-way crossover study under fasting conditions
| Arm | Type | Receives |
|---|---|---|
| Reference Drug | Active comparator | Drug: ParecoxibActive Ingredient: Parecoxib Dosage Form: Lyophilized powder for injection Strength: 40 mg/vial Dose: 40 mg (single intravenous bolus) |
| Test Drug | Experimental | Drug: ParecoxibActive Ingredient: Parecoxib Dosage Form: Lyophilized powder for injection Strength: 40 mg/vial Dose: 40 mg (single intravenous bolus) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParecoxibPharmacokinetic study under fasting conditions | Drug | Reference Drug, Test Drug |
Primary outcome
Peak plasma concentration (Cmax)
Time frame: 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
Time frame: 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-∞)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Parecoxib in people with Post-operative Pain and Bioequivalence Study in Healthy Subjects, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao-Kai Chang (TWN: 886-4-26875100 ext. 581, u51223@yungshingroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plasma concentration (Cmax) (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.