Bioequivalence study of piroxicam 20 mg tablet produced by PT Balatif in comparison with the comparator drug (Feldene® 20 mg Capsule manufactured by Farmasierra Manufacturing, S.L., Spain, under license of Pfizer S.L., Spain) when administered under fasting condition in healthy subjects

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-8GY4WFQT
Tanggal Input Registry : 12-03-2025

13-11-2024
AUC0-t dan Cmax
 
Bioequivalence study of piroxicam 20 mg tablet produced by PT Balatif in comparison with the comparator drug (Feldene® 20 mg Capsule manufactured by Farmasierra Manufacturing, S.L., Spain, under license of Pfizer S.L., Spain) when administered under fasting condition in healthy subjects
Bioequivalence study of piroxicam 20 mg tablet produced by PT Balatif in comparison with the comparator drug (Feldene® 20 mg Capsule manufactured by Farmasierra Manufacturing, S.L., Spain, under license of Pfizer S.L., Spain) when administered under fasting condition in healthy subjects
Interventional
The participating subjects were given orally one test drug (piroxicam 20 mg tablet produced by PT Balatif) or one comparator drug (Feldene® 20 mg Capsule manufactured by Farmasierra Manufacturing, S.L., Spain, under license of Pfizer S.L., Spain) after an overnight fast of at least 8 hours with approximately 200 mL of water at ambient temperature.
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Inclusion Criteria:

(1) Able to participate, communicate well with the investigators and would provide written informed consent to participate in the study, (2) Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation, (3) Aged 18 – 55 years inclusive, (4) Preferably non-smokers or smoke less than 10 cigarettes per day, (5) Body mass index within 18 to 25 kg/m2, (6) Vital signs (after 10 minutes rest) were within the following ranges (Systolic blood pressure : 100 – 129 mmHg, Diastolic blood pressure : 60 – 84 mmHg, Pulse rate : 60 – 90 bpm), (7) Willing to practice abstention or non-hormonal contraception during the study.

Exclusion Criteria:

(1) History of allergy or hypersensitivity or contraindication to piroxicam or other NSAIDs or allied drug, (2) Pregnant or lactating female (urinary pregnancy test will be applied to female subjects at screening and before taking the drug study), (3) Any major illness in the past 90 days or clinically significant ongoing chronic medical illness, (4) Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc, (5) Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV, (6) Clinically significant hematology abnormalities, (7) Clinically significant electrocardiogram (ECG) abnormalities, (8) Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery, (9) Past history of anaphylaxis or angioedema, (10) History of drug or alcohol abuse within 12 months prior to screening for this study, (11) Participation in any clinical trial within the past 90 days calculated from the last visit to this study’s first dosing day, (12) History of any bleeding or coagulative disorders, (13) Presence of difficulty in accessibility of veins in left or right arm during screening, (14) A donation or significant blood loss within 90 days before this study’s first dosing day, (15) Intake of any prescription (especially piroxicam and other NSAIDs), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day.
 
S-596/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
BE. 883/EQL/2024
Ronal Simanjuntak – PT Equilab International