Bioeqivalence study of Escitalopram 20 mg film coated caplet manufactured by PT Mersifarma Tirmaku Mercusana In comparison with Escitalopram 20 mg film coated tablet Cipralex® manufactured by H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby, Denmark; Registered by PT Pyridam Farma, Tbk, Jakarta, Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT. Mersifarma Tirmaku Mercusana
Mitra Pelaksana:
-
No Registry
INA-Y77M0HO
Tanggal Input Registry : 23-07-2024
Tracking Information | |
---|---|
Tanggal Antisipasi Studi | 12-03-2024 |
Outcome Primer | AUC0-t, Cmax |
Outcome Skunder | AUC0-inf , Tmax, Half life |
Descriptive Information | |
Judul Penelitian Popular | Bioeqivalence study of Escitalopram 20 mg film coated caplet manufactured by PT Mersifarma Tirmaku Mercusana In comparison with Escitalopram 20 mg film coated tablet Cipralex® manufactured by H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby, Denmark; Registered by PT Pyridam Farma, Tbk, Jakarta, Indonesia |
Judul Penelitian Ilmiah | Bioeqivalence study of Escitalopram 20 mg film coated caplet manufactured by PT Mersifarma Tirmaku Mercusana In comparison with Escitalopram 20 mg film coated tablet Cipralex® manufactured by H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby, Denmark; Registered by PT Pyridam Farma, Tbk, Jakarta, Indonesia |
Jenis Penelitian | Interventional |
Intervensi | Escitalopram 20 mg film coated caplet, manufactured by PT Mersifarma Tirmaku Mercusana |
Jumlah Subyek Penelitian | 20 |
Recruitment Information | |
Eligibility Criteria | 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 sign, 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 < 37.5oC f. Have 12-lead ECG without significant abnormalities. g. Do not have symptoms of Covid-19 and a history of close contact with Covid-19 patients. h. Have received the primary SARS-CoV-2 vaccine complete and at least the first booster.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 prenancy test will be performed on screening day and prior 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 to 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 of 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, distirbution, 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, SGOT, alkaline phospate, total bilirubin ≥ 1.5 ULN) n. Positive result of HBsAg, HCV, and/or HIV test |
Administrative Information | |
Nomor Persetujuan Etik | KET-1320/UN2.F1/ETIK/PPM.00.02/2023 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
Other Study ID Numbers | |
Contact Person | apt. Erma Suryani, S.Si |