Bioequivalence Study of Erlotinib 150 mg Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with Tarceva® 150mg Film-Coated Tablets Manufactured by Roche SpA, Segrate, Italy, Imported By PT. Boehringer Ingelheim Indonesia.

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-K8ARASK
Tanggal Input Registry : 14-03-2022

31-03-2021
To investigate whether erlotinib 150 mg film-coated tablets manufactured by PT. Global Onkolab Farma is bioequivalent to its reference product, Tarceva® 150 mg film-coated tablets manufactured by Roche SpA, Segrate, Italy, imported by PT. Boehringer Ingelheim Indonesia.
N/A
 
Bioequivalence Study of Erlotinib 150 mg Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with Tarceva® 150mg Film-Coated Tablets Manufactured by Roche SpA, Segrate, Italy, Imported By PT. Boehringer Ingelheim Indonesia.
Bioequivalence Study of Erlotinib 150 mg Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with Tarceva® 150mg Film-Coated Tablets Manufactured by Roche SpA, Segrate, Italy, Imported By PT. Boehringer Ingelheim Indonesia.
Eksperimental
Subjects were given a single dose of 1 film-coated tablet of the drug (Erlotinib 150 mg film-coated tablets or Tarceva® 150 mg film-coated tablets) under fasted condition. The drug was administered with 240 mL water.
34
 

Inclusion Criteria:

- have read the subject information and signed informed consent documents - healthy male subject - age 18 – 55 years - body mass index between 18–25 kg/m2 - have a normal electrocardiogram - blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg) - heart rate within normal range (60-100 bpm) - with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening - acceptance to use protection (condom) during intercourse with their spouse throughout the study (until the last day of blood sampling)

Exclusion Criteria:

- those who are female. - those with a history of contraindication or hypersensitivity to erlotinib, or other tyrosine kinase inhibitor drugs, 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 a history or presence of any coagulation disorder or clinically significant hematology abnormalities - those who are 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 have participated in any clinical study within 3 months prior to the study (< 90 days) - those who have donated or lost 300 ml (or more) of blood within 3 months prior to the study - those who smoke - those with history of travelling to another city within last 14 days - those with history of direct contact with a COVID-19 positive person in the subject neighborhood - those with history or present of sore throat, fever (with temperature more than 37°C) or dyspnea (short of breath) within last 14 days - those who are positive to swab antigen SARS CoV-2 test - those who are 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 are unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-950/UN2.f1/ETIK/PPM.00.02/2019
RG.01.02.321.03.21.00053/UB
480/STD/PML/2019
Nabila Mudin S