Bioequivalence Study of 250 mg Gefitinib Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with 250 mg Iressa® Film-Coated Tablets Manufactured by Kagamishi Plant, Nipro Pharma Corporation, Japan, Imported by PT. Astra Zeneca Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-D6RBKDP
Tanggal Input Registry : 04-03-2024

23-06-2023
Cmax, AUCt
 
Bioequivalence Study of 250 mg Gefitinib Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with 250 mg Iressa® Film-Coated Tablets Manufactured by Kagamishi Plant, Nipro Pharma Corporation, Japan, Imported by PT. Astra Zeneca Indonesia
Bioequivalence Study of 250 mg Gefitinib Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with 250 mg Iressa® Film-Coated Tablets Manufactured by Kagamishi Plant, Nipro Pharma Corporation, Japan, Imported by PT. Astra Zeneca Indonesia
Interventional
250 mg Gefitinib film-coated tablets
30
 

Inclusion Criteria:

Subjects had read the subject information and signed informed consent documents, Subjects healthy male, Subjects age range from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had blood pressure within normal range (systolic 90 – 120 mmHg and diastolic 60 – 80 mmHg), Subjects had heart rate within normal range (60 – 100 bpm), Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, Subjects agreed to use an acceptable method of birth control such as sexual abstinence or contraception (condom) from screening until 1 week after last dose of study drug

Exclusion Criteria:

Those with a history of contraindication or hypersensitivity to gefitinib or other ingredients in the study products or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction, Those with a history or presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, Those with history or presence of functional gastrointestinal disease or inadequate secretion of gastric acid or is treated for a acid suppression e.g., gastro upset, dyspepsia, gastritis, gastric ulcer, duodenal ulcer, etc, Those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities, Those with a history or presence of ocular surface damaging diseases (such as corneal perforation, ulcers, etc.), Those who suffering from a serious illness or having undergone major surgical procedures within 1 years before the first dose study, Those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug (CYP3A4 inhibitors/inducers, medicines that increase gastric pH, CYP2D6 substrates), within 1 week or at least 5 half-lives since the last dose of such drug prior to the drug administration day, Those who had participated in any clinical study within 3 months prior to the study (< 90 days), Those who had have donated or lost 300 mL (or more) of blood within 3 months prior to the study, Those who smoked, Those who were positive to swab antigen SARS CoV-2 test Those who with a history of travelling to another city within the last 14 days without following health authority regulation, Those who with a history of direct contact with a confirmed COVID-19 positive person in the subject’s neighborhood within 5 days prior to screening Those who with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea within the last 14 days, Those who was positive to 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 unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-1064/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
623/STD/PML/2021
Nabila Mudin S