Bioequivalence Study of 500 mg Capecitabine Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with 500 mg Xeloda® Film-Coated Tablets Manufactured by Excella GmbH & Co KG, Feucht, Germany for F. Hoffmann-La Roche Ltd, Basel, Switzerland, Imported by PT. Boehringer Ingelheim Indonesia, Bogor, Indonesia.

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-W5R2TS5
Tanggal Input Registry : 16-11-2022

13-07-2022
90% Confidence Interval, Cmax and AUCt
N.A
 
Bioequivalence Study of 500 mg Capecitabine Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with 500 mg Xeloda® Film-Coated Tablets Manufactured by Excella GmbH & Co KG, Feucht, Germany for F. Hoffmann-La Roche Ltd, Basel, Switzerland, Imported by PT. Boehringer Ingelheim Indonesia, Bogor, Indonesia.
Bioequivalence Study of 500 mg Capecitabine Film-Coated Tablets Manufactured by PT. Global Onkolab Farma in Comparison with 500 mg Xeloda® Film-Coated Tablets Manufactured by Excella GmbH & Co KG, Feucht, Germany for F. Hoffmann-La Roche Ltd, Basel, Switzerland, Imported by PT. Boehringer Ingelheim Indonesia, Bogor, Indonesia.
Eksperimental
Subjects were given a single dose of 500 mg Capecitabine of test drug or of reference drug with 240 mL of water.
57
 

Inclusion Criteria:

- had read the subject information and signed informed consent documents - 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:

- those who were pregnant and/or nursing condition - those with a history of contraindication or hypersensitivity to capecitabine or its metabolites and to fluoropyrimidine therapy or known sensitivity to 5-fluorouracil, 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 one 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 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 - 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 SARS CoV-2 antigen test - 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-916/UN2.F1/ETIK/PPM.00.02/2021
RG.01.02.321.11.22.01353/UB
575/STD/PML/2020
Nabila Mudin S