Bioequivalence Study of Quetiapine 300 mg Extended-Release Tablets Manufactured by PT Amarox Pharma Global in Comparison with Seroquel XR® 300 mg Extended-Release Tablets Manufactured by AstraZeneca Pharmaceuticals LP, Newark, USA, Packed and Released by AstraZeneca Pharmaceutical Co. Ltd., Wuxi, China, Imported by PT AstraZeneca Indonesia, Cikarang, Indonesia in Healthy Subjects under Fasting Condition

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-7Y1G861B
Tanggal Input Registry : 04-04-2025

17-01-2025
Cmax and AUCt
 
Bioequivalence Study of Quetiapine 300 mg Extended-Release Tablets Manufactured by PT Amarox Pharma Global in Comparison with Seroquel XR® 300 mg Extended-Release Tablets Manufactured by AstraZeneca Pharmaceuticals LP, Newark, USA, Packed and Released by AstraZeneca Pharmaceutical Co. Ltd., Wuxi, China, Imported by PT AstraZeneca Indonesia, Cikarang, Indonesia in Healthy Subjects under Fasting Condition
Bioequivalence Study of Quetiapine 300 mg Extended-Release Tablets Manufactured by PT Amarox Pharma Global in Comparison with Seroquel XR® 300 mg Extended-Release Tablets Manufactured by AstraZeneca Pharmaceuticals LP, Newark, USA, Packed and Released by AstraZeneca Pharmaceutical Co. Ltd., Wuxi, China, Imported by PT AstraZeneca Indonesia, Cikarang, Indonesia in Healthy Subjects under Fasting Condition
Interventional
Quetiapine 300 mg Extended-Release Tablets
28
 

Inclusion Criteria:

Subjects had read the subject information and were able to give written informed consent for participation in the study and comply with the study protocol/procedures, Subjects were healthy male and female, Subjects’ age ranges from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following ranges, Systolic blood pressure: 110 – 129 mmHg, Diastolic blood pressure: 70 – 84 mmHg, Pulse/Heart rate: 60 – 100 beats per minute, Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

those who were pregnant and/or nursing condition, those with a history of hypersensitivity or contraindication to quetiapine or allied 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/intestine surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease, those who had history or presence of any coagulation disorder or clinically significant hematology abnormalities, those who disagreed to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse within study period, 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 prior to the drug administration day, those who had participated in any clinical study within the past 90 days prior to the study, 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 or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea with in the last 14 days, those who were positive result for HIV, HbsAg, and HCV tests (to be kept confidential), those were had 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-1673/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
868/STD/PML/2024
Nabila Mudin S