Bioequivalence Study of Imatinib Mesylate 400 mg Film-Coated Tablets Manufactured by PT Global Onkolab Farma in Comparison with Glivec® 400 mg Film-Coated Tablets Manufactured by Novartis Pharma Stein A.G., Stein, Switzerland, Imported by PT. Novartis Indonesia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-LXQT46H
Tanggal Input Registry : 26-07-2023

14-10-2022
Geometric Means Ratio (%), 90% CI of the GMR (%),Intra-subject CV (%) of Cmax and AUct
 
Bioequivalence Study of Imatinib Mesylate 400 mg Film-Coated Tablets Manufactured by PT Global Onkolab Farma in Comparison with Glivec® 400 mg Film-Coated Tablets Manufactured by Novartis Pharma Stein A.G., Stein, Switzerland, Imported by PT. Novartis Indonesia.
Bioequivalence Study of Imatinib Mesylate 400 mg Film-Coated Tablets Manufactured by PT Global Onkolab Farma in Comparison with Glivec® 400 mg Film-Coated Tablets Manufactured by Novartis Pharma Stein A.G., Stein, Switzerland, Imported by PT. Novartis Indonesia.
Observational
24
 

Inclusion Criteria:

The inclusion criteria were healthy subjects who/with: - had read the subject information and signed informed consent documents - were healthy male and female - age range from 18 – 55 years - body mass index between 18 – 25 kg/m2 - had a normal electrocardiogram - had the blood pressure within normal range (systolic 90 - 120 mmHg and diastolic 60 - 80 mmHg) - had the heart rate within normal range (60 – 100 bpm) - had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. - had acceptance to use an acceptable method of birth control such as sexual abstinence or contraception (except hormonal contraception) from screening until 1 week after last dose of study drug; OR post-menopausal females (least 12 consecutive months with no menstruation without an alternative medical cause); OR surgically sterilized females with documented evidence.

Exclusion Criteria:

Exclusion criteria This study was not eligible for: - those who were pregnant and/or nursing condition - those with a history of contraindication or hypersensitivity to imatinib mesylate or other protein-tyrosine kinase inhibitor 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 any coagulation disorder or clinically significant hematology abnormalities. - those who were 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 two weeks 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 donated or lost 300 mL (or more) of blood within 3 months prior to the study. - those who were smoker - those with a history of travelling to another city within the last 14 days without following health authority regulation - those with a history of direct contact with a COVID-19 positive person in the subject’s neighborhood within 3 days prior to screening - those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days - those who were positive to rapid (swab) antigen test of SARS CoV-2 - those who were 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 were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-941/UN2.F1/ETIK/PPM.00.02/2021
Not applicable
PPUK/PPUB number
Not available
Nabila Mudin S