Bioequivalence Study of Ticagrelor 90 mg Film-Coated Tablets Manufactured by PT. Hexpharm Jaya for PT. Kalbe Farma Tbk in Comparison with Brilinta® 90 mg Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd, China, Imported by AstraZeneca Indonesia, Bekasi, Indonesia.
Tahapan Penelitian : Complete
Sponsor:
PT. Kalbe Farma Tbk
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-ME8QS7
Tanggal Input Registry : 11-05-2022
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 10-01-2022 |
| Outcome Primer | Ticagrelor 90 mg Film-Coated Tablets Manufactured by PT. Hexpharm Jaya for PT. Kalbe Farma Tbk was bioequivalent toward its reference product, Brilinta® 90 mg Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd, China, Imported by AstraZeneca Indonesia, Bekasi, Indonesia. |
| Outcome Skunder | N/A |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Ticagrelor 90 mg Film-Coated Tablets Manufactured by PT. Hexpharm Jaya for PT. Kalbe Farma Tbk in Comparison with Brilinta® 90 mg Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd, China, Imported by AstraZeneca Indonesia, Bekasi, Indonesia. |
| Judul Penelitian Ilmiah | Bioequivalence Study of Ticagrelor 90 mg Film-Coated Tablets Manufactured by PT. Hexpharm Jaya for PT. Kalbe Farma Tbk in Comparison with Brilinta® 90 mg Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden, Packed and Released by AstraZeneca Pharmaceutical Co., Ltd, China, Imported by AstraZeneca Indonesia, Bekasi, Indonesia. |
| Jenis Penelitian | Interventional |
| Intervensi | Subjects were given a single dose of Ticagrelor 90 mg Film-Coated Tablets or Brilinta® 90 mg Film-Coated Tablets under fasted condition. The drug was administered with 240 mL water. |
| Jumlah Subyek Penelitian | 36 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: - healthy female or male - 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. - acceptance on obligation to use protection (condom) during intercourse with their spouse throughout the studyExclusion Criteria: - those who were pregnant and/or nursing women. - those with history of contraindication or hypersensitivity to ticagrelor, or other antiplatelets, 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 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-294/UN2.F1/ETIK/PPM.00.02/2021 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 560/STD/PML/2020 |
| Contact Person | Nabila Mudin S |