Bioequivalence Study of Celecoxib 200 mg (Celixa® 200) Capsule Manufactured by PT Interbat in Comparison with Celebrex® 200 mg Capsule Manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, Imported by PT Pfizer Indonesia - Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-B793ENB
Tanggal Input Registry : 23-07-2024

15-05-2024
Cmax, AUCt
 
Bioequivalence Study of Celecoxib 200 mg (Celixa® 200) Capsule Manufactured by PT Interbat in Comparison with Celebrex® 200 mg Capsule Manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, Imported by PT Pfizer Indonesia - Indonesia
Bioequivalence Study of Celecoxib 200 mg (Celixa® 200) Capsule Manufactured by PT Interbat in Comparison with Celebrex® 200 mg Capsule Manufactured by Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico, Imported by PT Pfizer Indonesia - Indonesia
Interventional
Celixa® 200 Capsule
30
 

Inclusion Criteria:

Subjects had read the subject information and were able to give written informed consent for participation in the study and complied with the study protocol/procedures, Subjects healthy male and female, Subjects’ age ranges from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following range:Systolic blood pressure: 90 – 129 mmHg, Diastolic blood pressure: 60 – 84 mmHg, Pulse/Heart rate: 60 – 100 beats per minute, Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, Subjects had received the complete primary SARS CoV-2 vaccine,Subjects had negative result of SARS CoV-2 antigen test (for those who has not received the first booster vaccine).

Exclusion Criteria:

Those who were pregnant and/or nursing women,Those with history of contraindication or hypersensitivity to celecoxib, or allied drugs, or other ingredients in the study products, or a history of serious allergic reaction to any drug, significant allergic disease, or allergic reaction, Those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, active peptic ulcer, diarrhea, gastric /intestinal surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease, Those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities, Those who disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout the study, Those who using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day, Those who participate in any clinical study within the past 90 days prior to the study, Those who donated or lost 300 mL (or more) of blood within 3 months prior to the study, Those who had smoking habit more than 10 cigarettes per day, Those with a history of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 14 days, Those with history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 days, Those who got positive results for HIV, HbsAg, and HCV tests (to be kept confidential), Those with a history of drug or alcohol abuse within 12 months prior to screening for this study,Those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-454/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
810/STD/PML/2024
Nabila Mudin S