bioequivalence study of Sulfasalazine 500 mg Enteric Coated Caplet manufactured by PT Bernofarm in comparison with Sulfasalazine 500 mg Enteric Coated Tablet, Salazopyrin® manufactured by Recipharm Uppsala AB, Sweden, Product Registration Holder by Pfizer (Malaysia) Sdn. Bhd., Malaysia under fasting condition

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-6E56BNT2
Tanggal Input Registry : 06-02-2025

20-09-2024
AUCt, Cmax
AUC0-inf , Tmax, Half life
 
bioequivalence study of Sulfasalazine 500 mg Enteric Coated Caplet manufactured by PT Bernofarm in comparison with Sulfasalazine 500 mg Enteric Coated Tablet, Salazopyrin® manufactured by Recipharm Uppsala AB, Sweden, Product Registration Holder by Pfizer (Malaysia) Sdn. Bhd., Malaysia under fasting condition
bioequivalence study of Sulfasalazine 500 mg Enteric Coated Caplet manufactured by PT Bernofarm in comparison with Sulfasalazine 500 mg Enteric Coated Tablet, Salazopyrin® manufactured by Recipharm Uppsala AB, Sweden, Product Registration Holder by Pfizer (Malaysia) Sdn. Bhd., Malaysia under fasting condition
Interventional
Sulfasalazine 500 mg Enteric Coated Caplet manufactured by PT Bernofarm
42
 

Inclusion Criteria:

a. Willing to participate and agree to sign informed consent and communicate well with the investigators. b. Healthy female/male subjects as determined by the medical screening assessments. c. Aged 18 - 55 years inclusive. d. Body mass index within the range of 18.00 - 25.00 kg/m2. e. Vital signs, after 10 minutes resting, within the following ranges: (i). Pulse rate: 60 - 90 bpm. (ii). Respiratory Rate: 12 - 20 x/minutes. (iii). Systolic blood pressure: 100 - 129 mmHg. (iv). Diastolic blood pressure: 60 - 84 mmHg. (v). Body temperature < 37.5°C f. Have 12-lead ECG without significant abnormalities. g. Do not have symptoms of Covid-19 and a history of close contact with Covid-19 patients h. Have received the primary SARS-CoV-2 vaccine complete and at least the first booster.

Exclusion Criteria:

a. Participate in another study within 3 (three) months prior to the first day of study drug administration. b. Pregnant or lactating female (urinary pregnancy test will be performed on screening day and prior study drug administrations on each period). c. Smoker or smoking more than 10 (ten) cigarettes per day. d. Intake of any prescription drug or non-prescription drug within 7 days prior to the first day of drug administration of this study. e. Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the first day of study drug administration. f. History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration. g. Known hypersensitivity, or contraindication to the study drug. h. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. i. History of any bleeding or coagulative disorders. j. Clinically significant hematology abnormalities. k. Clinically significant urinalysis abnormalities. l. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). m. History or presence of any liver dysfunction (SGPT, SGOT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). n. Positive result of HBsAg, HCV, and/or HIV test. o. Have a serious allergic condition/history or bronchial asthma, especially those with the potential to experience acute asthma attacks, urticaria, rhinitis or other allergic symptoms triggered by acetyl salicylic acid or other NSAIDs p. Have a G-6-PD deficiency condition. q. Haves the condition porphyria, because the test drug was reported to trigger acute attacks. r. Potential hypersensitivity to sulfasalazine, its metabolites as well as sulfonamides or salicylates.
 
KET-1030/UN2.F1/ETIK/PPM/00.02/2024
Not applicable
PPUK/PPUB number
018/BE/MAR-2024
Oktaviani Utami Dewi, S.Si - Ass. Manager QA