Bioequivalence Study of 20 mg Piroxicam Capsule (Novaxicam®) Manufactured by PT. Novapharin in Compared with 20 mg Feldene® Capsule Manufactured by Pfizer Pharmaceuticals Llc Ireland

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Equitrust Lab - PT Kimia Farma Diagnostika
No Registry
INA-PB0FH0X
Tanggal Input Registry : 14-09-2023

20-07-2023
1. Maximum plasma concentration (Cmax) [time points : 0 hours (before drug administration); 20 minutes; 40 minutes; 1 hours; 1,5 hours; 2 hours; 2,5 hours; 3 hours; 3,5 hours; 4 hours; 5 hours; 6 hours; 8 hours; 12 hours; 16 hours; 24 hours; 48 hours; and 72 hours after drug administration (17 time points)] 90% Confidence Interval (80-125) 2. Area Under Curve from 0 to 24 hours (AUCt) [time points : 0 hours (before drug administration); 20 minutes; 40 minutes; 1 hours; 1,5 hours; 2 hours; 2,5 hours; 3 hours; 3,5 hours; 4 hours; 5 hours; 6 hours; 8 hours; 12 hours; 16 hours; 24 hours; 48 hours; and 72 hours after drug administration (17 time points)] 90% Confidence Interval (80-125)
 
Bioequivalence Study of 20 mg Piroxicam Capsule (Novaxicam®) Manufactured by PT. Novapharin in Compared with 20 mg Feldene® Capsule Manufactured by Pfizer Pharmaceuticals Llc Ireland
Bioequivalence Study of 20 mg Piroxicam Capsule (Novaxicam®) Manufactured by PT. Novapharin in Compared with 20 mg Feldene® Capsule Manufactured by Pfizer Pharmaceuticals Llc Ireland
Interventional
The reference drug was 20 mg Feldene® Capsule Manufactured by Pfizer Pharmaceuticals Llc Ireland, Batch Number EW4078, Expiry Date June 30th 2024. The test drug was 20 mg Piroxicam Capsule (Novaxicam®) Manufactured by PT. Novapharin, Batch Number 2211-10-47, Manufacturing Date November 09th 2022, Expiry Date November 2024. In sampling day, subject took one dose of Piroxicam manufactured of either formulation (reference or test) as per randomization scheme with 1 capsule of 20 mg (to be taken with 220 mL of water) in sitting position.
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Inclusion Criteria:

Inclusion criteria The inclusion criteria for this study include: 1) Signed informed consent; 2) Healthy based on clinical laboratory tests (routine hematology, liver function, kidney function, blood glucose, urinalysis, hepatitis B (HBsAg), hepatitis C (Anti-HCV) and HIV (Anti-HIV), medical history, and physical examination); 3) Male and female subjects (if female, consider the risks for women of childbearing age and perform pregnancy tests); 4) Age between 18-55 years; 5) Normal weight range according to Body Mass Index (BMI) 18-25 kg/m2); 6) Vital signs within the following ranges: systolic blood pressure 110 - 129 mmHg, diastolic blood pressure 70 - 84 mmHg, normal pulse rate 60-90 bpm, oxygen saturation (SpO2) in the normal range of 95 - 100%, and normal respiratory rate of 12-20/min.

Exclusion Criteria:

The exclusion criteria for this study include: 1) Smoking more than 10 cigarettes per day; 2) Pregnant or breastfeeding women. Pregnancy tests was performed during screening and prior to the administration of the investigational or comparator drug; 3) History of kidney or liver disease, or history of allergy, hypersensitivity or contraindication to the investigational bioequivalence drug (Piroxicam); 4) Clinically significant hematological abnormalities; 5) Abnormal electrocardiogram (ECG); 6) Difficulty accessing veins in the left or right arm; 7) History of significant ongoing clinically or medically significant chronic or acute illness; 8) History of drug or alcohol abuse within the past 12 months (1 year) prior to screening for this study; 9) Positive serology test results for Hepatitis B (HBsAg), Hepatitis C (anti-HCV), HIV (anti-HIV). 10) Positive rapid antigen test results for SARS-CoV-2 (if the BE study is conducted during a pandemic). 11) History or condition that can affect drug kinetics. 12) Use of drugs or dietary supplements no more than 7 days since the start of the study. 13) Participation in previous clinical trials no more than 3 months from the start of the study. 14) Blood donation or blood loss of more than 300 ml within 3 months from the start of the study.
 
KET-650/UN2.F1/ETIK/PPM.00.02/2023
Not applicable
PPUK/PPUB number
Nungky Tri Yunica, S.T