Bioequivalence study of tenofovir disoproxil fumarate/ emtricitabine 300 mg/200 mg film-coated tablet produced by PT Kimia Farma Tbk. in comparison with the comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) when administered under fasting condition in healthy subjects

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Equilab International
No Registry
INA-LNARP0Q
Tanggal Input Registry : 03-02-2023

28-06-2022
The 90% CI of the test/comparator geometric mean ratios for AUC0-t and Cmax
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Bioequivalence study of tenofovir disoproxil fumarate/ emtricitabine 300 mg/200 mg film-coated tablet produced by PT Kimia Farma Tbk. in comparison with the comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) when administered under fasting condition in healthy subjects
Bioequivalence study of tenofovir disoproxil fumarate/ emtricitabine 300 mg/200 mg film-coated tablet produced by PT Kimia Farma Tbk. in comparison with the comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) when administered under fasting condition in healthy subjects
Interventional
The participating subjects were given orally one film-coated tablet of test drug (tenofovir disoproxil fumarate/emtricitabine 300 mg/200 mg film coated tablet produced by PT Kimia Farma Tbk.) or one tablet of comparator drug (Truvada® 300 mg/200 mg Tablet manufactured by Patheon Inc., Canada, under license of Gilead Sciences Inc., USA, imported by Gilead (Shanghai) Pharmaceutical Technology Co. Ltd., China) after an overnight fast with 200 mL of water.
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Inclusion Criteria:

Able to participate, communicate well with the investigators and would provide written informed consent to participate in the study; Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation; Aged 18 – 55 years; Preferably non-smokers or smoke less than 10 cigarettes per day; Body mass within 18 to 25 kg/m2; Vital signs (after 10 minutes rest) were within the following ranges: (Systolic blood pressure: 100 – 129 mmHg; Diastolic blood pressure: 60 – 84 mmHg; Pulse rate: 60 – 90 bpm); Willing to practice abstention or non-hormonal contraception during the study.

Exclusion Criteria:

History of allergy or hypersensitivity or contraindication to tenofovir disoproxil fumarate, emtricitabine, or allied drugs; Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug); Any major illness in the past 90 days or clinically significant ongoing chronic medical illness; Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc; Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV; Positive result for COVID-19 antigen rapid test; Clinically significant hematology abnormalities; Clinically significant electrocardiogram (ECG) abnormalities; Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery; Past history of anaphylaxis or angioedema; History of drug or alcohol abuse within 12 months prior to screening for this study; Participation in any clinical trial within the past 90 days calculated from the last visit until this study’s first dosing day; History of any bleeding or coagulative disorders; Presence of difficulty in accessibility of veins in left or right arm; A donation or significant blood loss within 90 days before this study’s first dosing day; Intake of any prescription, non-prescription drug, food supplements or herbal medicines within 21 days of this study’s first dosing day.
 
No. S-331/UN2.F1/ETIK/PPM.00.02/2022
BE 701-A/EQL/2021
Ronal Simanjuntak