Bioequivalence Study of 10 mg Olanzapine Film Coated Tablet, Manufactured by PT Prima Medika Laboratories, Registered by PT Pharos Indonesia (Remital®) in Comparison with the Innovator’s Film Coated Tablet (Zyprexa®), Manufactured or Registered by Eli Lilly (Suisse) S.A., Vernier/Gerneve
Tahapan Penelitian : Complete
Sponsor:
PT Pharos Indonesia
Mitra Pelaksana:
Sentra Uji BE Econolab
No Registry
INA-WZXQFTT
Tanggal Input Registry : 07-12-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 09-10-2023 |
| Outcome Primer | AUC0-t and Cmax |
| Outcome Skunder | AUC0-t, Tmax, T1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 10 mg Olanzapine Film Coated Tablet, Manufactured by PT Prima Medika Laboratories, Registered by PT Pharos Indonesia (Remital®) in Comparison with the Innovator’s Film Coated Tablet (Zyprexa®), Manufactured or Registered by Eli Lilly (Suisse) S.A., Vernier/Gerneve |
| Judul Penelitian Ilmiah | Bioequivalence Study of 10 mg Olanzapine Film Coated Tablet, Manufactured by PT Prima Medika Laboratories, Registered by PT Pharos Indonesia (Remital®) in Comparison with the Innovator’s Film Coated Tablet (Zyprexa®), Manufactured or Registered by Eli Lilly (Suisse) S.A., Vernier/Gerneve |
| Jenis Penelitian | Interventional |
| Intervensi | Single dose of 10 mg Olanzapine Film Coated Tablet (Remital®), Manufactured by PT Prima Medika Laboratories, Registered by PT Pharos Indonesia |
| Jumlah Subyek Penelitian | 20 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Able to participate, communicate well with the investigators and agree to sign an informed consent; Willing to use contraception (condoms) when intercourse with spouse during the study; Healthy male/female subjects as determined by the medical screening assessments; Aged 18-55 years of age; Body mass index (BMI) is in the range of 18-25 kg/m2; Normal blood pressure (systolic 100-120 mmHg; diastolic 60-80 mmHg); normal pulse rate (60-90 bpm); Normal electrocardiogram (ECG); Clinical laboratory results have to be within normal range.Exclusion Criteria: Pregnant or lactating women (urinary pregnancy test to be applied to female subjects when screening and just before taking the test or innovator drug); Known hypersensitivity or contraindication to the study drug or other antipsychotic drug; Intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within 7 days of this study’s first dosing day; History of any bleeding or coagulation disorders; Any surgical or medical condition (present or history) which might significantly alters the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery; A donation or loss of 300 mL (or more) of blood within 3 months before this study’s first dosing day; A positive Hepatitis B surface antigen (HBsAg), HCV, HIV test result; History of drug or alcohol abuse within 12 months prior to this study; Heavy Smoker (more than 10 cigarettes a day); Clinically have significant bleeding within 3 months prior to the study; Participation in a previous study within 3 months of this study’s first dosing day; Patient with history of orthostatic hypotension, multiple syncopal episodes, epilepsy/seizure, primary psychiatric/neurological diagnosis; Patients with known risk of narrow-angle glaucoma. |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-1171/UN2.F1/ETIK/PPM.00.02/2022 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | PRO-267/22/ECL |
| Contact Person | Ni Made Dwi Wulandari |