Bioequivalence study of Efavirenz 600 mg Film-Coated Tablet, Efanex manufactured by PT Amarox Pharma Global in comparison with Efavirenz 600 mg Tablet, Sustiva ® manufactured and distributed by Bristol-Myers Squibb Company Princeton, NJ 08543 USA

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Biometrik Riset Indonesia
No Registry
INA-YFRGA38
Tanggal Input Registry : 10-02-2023

03-10-2022
90 % CI for AUC0-t and Cmax
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Bioequivalence study of Efavirenz 600 mg Film-Coated Tablet, Efanex manufactured by PT Amarox Pharma Global in comparison with Efavirenz 600 mg Tablet, Sustiva ® manufactured and distributed by Bristol-Myers Squibb Company Princeton, NJ 08543 USA
bioequivalence study of Efavirenz 600 mg Film-Coated Tablet, Efanex manufactured by PT Amarox Pharma Global in comparison with Efavirenz 600 mg Tablet, Sustiva ® manufactured and distributed by Bristol-Myers Squibb Company Princeton, NJ 08543 USA
Interventional
The reference drug was the market available Sustiva® (Efavirenz 600 mg) film coated tablet manufactured by Bristol-Myers Squibb Company Princeton, NJ 08543 USA; Batch number : ABQ5724A1; expired date : March 2023. The test drug was Efanex (Efavirenz 600 mg) film coated tablet manufactured by PT Amarox Pharma Global; Batch number : 08521F01G; manufacturing date : June 2021; expired date : May 2023. In sampling day subjects took one dose of Efavirenz products of either formulation (reference or test) after an overnight fast, as per randomization scheme with 250 mL of water in sitting position. The subjects blood samples will be taken at a certain times.
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Inclusion Criteria:

a. Willing to participate and agree to sign informed consent and communicate well with the investigators. b. Healthy female/male subjects as determined by the medical screening assessments. c. Aged 18 - 55 years inclusive. d. Body mass index within the range of 18.00 - 25.00 kg/m2. e. Vital signs, after 10 minutes resting, within the following ranges: (i). Pulse rate: 60 - 90 bpm. (ii). Respiratory Rate: 12 - 20 x/minutes. (iii). Systolic blood pressure: 100 - 129 mmHg. (iv). Diastolic blood pressure: 60 - 84 mmHg. (v). Body Temperature < 37.5°C f. Have 12-lead ECG without significant abnormalities. g. Willing to use protection (condoms) when having sex during the bioequivalence study. h. Negative results of rapid test antigen Covid-19 at screening process.

Exclusion Criteria:

a.Participate in another study within 3 (three) months prior to the first day of study drug administration. b. Pregnant or lactating female (urinary pregnancy test will be performed at screening day and prior to study drug administrations on each period). c. Smoker or smoking more than 10 (ten) cigarettes per day. d. Intake of any prescription drug or non-prescription drug within 7 days prior the first day of drug administration of this study. e. Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the first day of study drug administration. f. History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration. g. Known hypersensitivity or contraindication to the study drug. h. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. i. History of any bleeding or coagulative disorders. j. Clinically significant hematology abnormalities. k. Clinically significant urinalysis abnormalities. l. Renal insufficiency (plasma’s creatinine concentration ≥ 1.50 mg/dL). m. History or presence of any liver dysfunction (SGPT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). n. Positive result of HBsAg, HCV, and/or HIV test.
 
KET-609/UN2.F1/ETIK/PPM.00.02/2022; S-497/UN2/F1/ETIK/PPM.00.02/2022
079/BE/APR-2022
Nada Mawaddah - Supervisor Klinis PT Biometrik Riset Indonesia