Bioequivalence Study of Generic Celecoxib 200 mg Capsules

NCT06337422 | Not Yet Recruiting Phase 1

• 1 other identifier: BE21-023
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions

Conditions

Healthy Volunteer

Keywords

Celecoxib 200 mg Capsules

Outcome Measures

Primary Outcomes (2)

• Bioequivalence based on Cmax period

  Bioequivalence based on Cmax period

  Through 72 Hours Post Dose

• Bioequivalence based on AUC parameters

  Bioequivalence based on AUC parameters

  Through 72 Hours Post Dose

Study Arms (2)

Generic celecoxib 200 mg capsule

EXPERIMENTAL

Generic celecoxib 200 mg capsule. The test product will be formulated using the same active ingredient with the same strength as the reference product, CELEBREX™. The test product to be used in this bioequivalence study is prepared in accordance with GMP regulations.

Drug: Celecoxib 200 mg capsule

Celecoxib 200 mg capsule

ACTIVE COMPARATOR

Celecoxib 200 mg capsule, CELEBREX™, has been registered with Food and Drug Administration, Thailand (TFDA).

Drug: Celecoxib 200 mg capsule

Interventions

Celecoxib 200 mg capsule DRUG

Celecoxib 200 mg capsule

Also known as: CELEBREX™

Celecoxib 200 mg capsule; Generic celecoxib 200 mg capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Thai male or female subjects between the ages of 18 to 55 years
• Body mass index between 18.0 to 30.0 kg/m2.
• Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study
• Non-pregnant woman (negative pregnancy test) and not currently breast feeding
• Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:
• Postmenopausal for at least 1 year or
• Surgic ally sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
• Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
• Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.

You may not qualify if:

• History of allergic reaction or hypersensitivity to celecoxib, sulfonamide, acetylsalicylic acid (aspirin), other NSAIDs including other cyclooxygenase-2 specific inhibitors or any other ingredient of the product
• History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
• Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
• History about administration of first dose or second dose of COVID-19 vaccine within 30 days prior to check-in in each Period.
• History or evidence of cerebrovascular disease, myocardial infraction, congestive heart failure, coronary heart disease (stenosed or occluded) or paresis due to cerebrovascular accident
• History or evidence of cardiovascular bleeding, gastrointestinal bleeding, gastric or duodenal or peptic ulcer
• History or evidence of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption
• History of sensitivity to heparin or heparin-induced thrombocytopenia
• History of problems with swallowing tablet or capsule
• Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
• History of diarrhea, vomiting or dehydration within 24 hours prior to check-in in each period
• History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
• lead ECG demonstrating QTc \>450 msec, a QRS interval \>120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility.
• Investigation with blood sample shows positive test for HBsAg
• Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test

Sponsors & Collaborators

• International Bio service: lead

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Uthai Suvanakoot, Ph. D

  International Bio service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paweena Boonprakong

CONTACT

024415211; paweena.bon@mahidol.ac.th

Thanaporn Wongyai, B.Sc.Pharm

CONTACT

024415211; thanaporn.won@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 29, 2024
• Study Start: September 23, 2024
• Primary Completion: September 27, 2024
• Study Completion: October 4, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share