Bioequivalence Study of 20 mg Omeprazole (Lokev®) Delayed-Release Capsule Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with 20 mg Losec® Capsule Manufactured by AstraZeneca AB, Soedertalie, Sweden, Imported by PT. AstraZeneca Indonesia.
Tahapan Penelitian : Complete
Sponsor:
PT IFARS Pharmaceutical Laboratories
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-RYRAQTO
Tanggal Input Registry : 19-07-2022
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 29-10-2021 |
| Outcome Primer | To investigate whether 20 mg Omeprazole (Lokev®) Delayed-Release capsule manufactured by PT IFARS Pharmaceutical Laboratories is bioequivalent to its reference product, 20 mg Losec® capsule manufactured by AstraZeneca AB, Soedertalie, Sweden, imported by PT. AstraZeneca Indonesia. |
| Outcome Skunder | N/A |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 20 mg Omeprazole (Lokev®) Delayed-Release Capsule Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with 20 mg Losec® Capsule Manufactured by AstraZeneca AB, Soedertalie, Sweden, Imported by PT. AstraZeneca Indonesia. |
| Judul Penelitian Ilmiah | Bioequivalence Study of 20 mg Omeprazole (Lokev®) Delayed-Release Capsule Manufactured by PT IFARS Pharmaceutical Laboratories in Comparison with 20 mg Losec® Capsule Manufactured by AstraZeneca AB, Soedertalie, Sweden, Imported by PT. AstraZeneca Indonesia. |
| Jenis Penelitian | Interventional |
| Intervensi | subjects were given a single dose of 20 mg omeprazole of either formulation (20 mg Lokev® Delayed-Release capsule or 20 mg Losec® capsule) with 240 mL of water |
| Jumlah Subyek Penelitian | 33 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: -had read the subject information and signed informed consent documents -age range from 18 – 55 years -body mass index between 18–25 kg/m2 -had a normal electrocardiogram -had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg) -had the heart rate within normal range (60 – 100 bpm) -had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. -accepted to use protection (condom) before any intercourse with their spouse throughout the studyExclusion Criteria: -those who were pregnant and/or nursing women (for women). -those with history of contraindication or hypersensitivity to omeprazole, or other proton pump inhibitor drugs or other ingredients in the drugs 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 pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease. -those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities. -those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day. -those who had participated in any clinical study within 3 months prior to the study ( |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-618/UN2.F1/ETIK/PPM.00.02/2021 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 613/STD/PML/2021 |
| Contact Person | Nabila Mudin S |