Bioequivalence Study of Alprazolam 1 mg Tablet Manufactured by PT Interbat in Comparison with Xanax® 1 mg Kaptab Manufactured by Pfizer Pharmaceutical LLC, Barceloneta, Puerto Rico, Packaged and Released by Pfizer Italia S.r.l., Ascoli, Italia, Imported by PT Pfizer Indonesia, Jakarta, Indonesia in Healthy Subjects under Fasting Condition.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-6K87FOWC
Tanggal Input Registry : 07-08-2025

04-06-2025
The objective of this study is to investigate whether Alprazolam 1 mg tablet manufactured by PT Interbat is bioequivalent to its reference product, Xanax® 1 mg kaptab manufactured by Pfizer Pharmaceutical LLC, Barceloneta, Puerto Rico, packaged and released by Pfizer Italia S.r.l., Ascoli, Italia, imported by PT Pfizer Indonesia, Jakarta, Indonesia in healthy subjects under fasting condition.
 
Bioequivalence Study of Alprazolam 1 mg Tablet Manufactured by PT Interbat in Comparison with Xanax® 1 mg Kaptab Manufactured by Pfizer Pharmaceutical LLC, Barceloneta, Puerto Rico, Packaged and Released by Pfizer Italia S.r.l., Ascoli, Italia, Imported by PT Pfizer Indonesia, Jakarta, Indonesia in Healthy Subjects under Fasting Condition.
Bioequivalence Study of Alprazolam 1 mg Tablet Manufactured by PT Interbat in Comparison with Xanax® 1 mg Kaptab Manufactured by Pfizer Pharmaceutical LLC, Barceloneta, Puerto Rico, Packaged and Released by Pfizer Italia S.r.l., Ascoli, Italia, Imported by PT Pfizer Indonesia, Jakarta, Indonesia in Healthy Subjects under Fasting Condition.
Interventional
Alprazolam 1 mg Tablet
24
 

Inclusion Criteria:

1. 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 2. Subjects were healthy male and female 3. Subjects’ age ranges from 18 – 55 years 4. Subjects’ body mass index between 18 – 25 kg/m2 5. Subjects had a normal electrocardiogram 6. Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following ranges: - Normal body temperature (≤ 37.5°C) - Normal respiration rate (12 - 20 respirations per minute) - Pulse/Heart rate: 60 – 100 beats per minute - Systolic blood pressure: 90 – 129 mmHg - Diastolic blood pressure: 60 – 84 mmHg 7. Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

1. those who were pregnant and/or nursing condition 2. those with a history of hypersensitivity or contraindication to alprazolam or allied drugs, or other ingredients in the study products, or a history of serious allergic reaction to any drug, significant allergic disease, or allergic reaction 3. 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 4. those who had history or presence of any coagulation disorder, or clinically significant hematology abnormalities 5. those who having history or presence of myasthenia gravis 6. those who having history or presence of acute narrow angle glaucoma 7. those who disagreed to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse within study period until 7 (seven) days after the last drug administration 8. those who was 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 9. those who participated in any clinical study within the past 90 (ninety) days prior to the study 10. those who donated or lost 300 mL (or more) of blood within 3 (three) months prior to the study 11. those who was smoker 12. those who had history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 (fourteen) days 13. those who was positive to HIV, HBsAg, and HCV tests (to be kept confidential) 14. those who had history of drug or alcohol abuse within 12 (twelve) months prior to screening for this study 15. those who had positive results for drugs (opioid, amphetamine, benzodiazepines, and cannabis) and alcohol 16. Those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, poor venous access
 
KET-375/UN2.F1/ETIK/PPM.00.02/2025
Not applicable
PPUK/PPUB number
884/STD/PML/2024
Nabila Mudin S