BIOEQUIVALENCE STUDY OF CANDESARTAN CILEXETIL 8 MG + AMLODIPINE BESYLATE 5 MG TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH UNISIA® (CANDESARTAN CILEXETIL 8 MG + AMLODIPINE 5 MG) TABLET PRODUCED BY TAKEDA PHARMACEUTICAL COMPANY LTD., HIKARI, JAPAN
Tahapan Penelitian : Complete
Sponsor:
PT Pratapa Nirmala
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-SN7GB2
Tanggal Input Registry : 31-01-2022
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 21-09-2021 |
| Outcome Primer | NA |
| Outcome Skunder | NA |
| Descriptive Information | |
| Judul Penelitian Popular | BIOEQUIVALENCE STUDY OF CANDESARTAN CILEXETIL 8 MG + AMLODIPINE BESYLATE 5 MG TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH UNISIA® (CANDESARTAN CILEXETIL 8 MG + AMLODIPINE 5 MG) TABLET PRODUCED BY TAKEDA PHARMACEUTICAL COMPANY LTD., HIKARI, JAPAN |
| Judul Penelitian Ilmiah | BIOEQUIVALENCE STUDY OF CANDESARTAN CILEXETIL 8 MG + AMLODIPINE BESYLATE 5 MG TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH UNISIA® (CANDESARTAN CILEXETIL 8 MG + AMLODIPINE 5 MG) TABLET PRODUCED BY TAKEDA PHARMACEUTICAL COMPANY LTD., HIKARI, JAPAN |
| Jenis Penelitian | Interventional |
| Intervensi | Test drug: Candesartan cilexetil 8 mg + Amlodipine besylate 5 mg tablet produced by PT Pratapa Nirmala Reference drug: Unisia® (Candesartan cilexetil 8 mg + Amlodipine 5 mg) tablet produced by Takeda Pharmaceutical Company Ltd., Hikari, Japan. |
| Jumlah Subyek Penelitian | 26 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: - Willing to sign the informed consent - Healthy male/female (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood sugar and urinalysis; history of disease, and physical examination), - Age 18 – 55 years, - Body mass index between 18 – 25 kg/m2, - Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 60-80 mmHg), heart rate 60 – 90 beats per minute, - Show normal result or within the acceptance range (not clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test resultExclusion Criteria: - With history of hypersensitivity to Candesartan cilexetil and Amlodipine or other related drug, - With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, - Who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day, - Who have participated in any clinical study within 3 month prior the study, - Who have donated or lost 300 mL (or more) of blood within 3 months prior the study, - Who smoke more than 10 sticks of cigarettes a day, - Who have any bleeding or coagulation disorder, - Who indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV, - With the history of alcohol and drug abuse, - Pregnant or lactating women - Female subjects who give positive pregnancy test at pre-study examination - If the study is conducted in Covid-19 pandemic situation, the exclusions criteria bellow must be applied: a.Those with history of travelling to another city within last 14 days b.Those with history of direct contact with a Covid-19 positive person in the subject neighborhood c.Those with history or present sore throat, fever (with temperature more than 37oC) or short of breath within last 14 days d.Those who give positive results on Covid-19 rapid test |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-196/UN2.F1/ETIK/PPM.00.02/2021 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 122/FORM/OMF/2020 ver. 00 |
| Contact Person | apt. Haranissa Dea Oktania |