Bioequivalence Study of 15 mg Pioglitazone & 500 mg Metformin Tablets Manufactured by PT. Dankos Farma (Pionix M 500) in Comparison with Metact® Combination Tablets LD 15/500 Manufactured by Teva Takeda Pharma Ltd., Japan
Tahapan Penelitian : Complete
Sponsor:
PT Kalbe Farma Tbk
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-4F6QO2Z
Tanggal Input Registry : 14-05-2024
Tracking Information | |
---|---|
Tanggal Antisipasi Studi | 19-11-2023 |
Outcome Primer | Cmax, AUCt |
Outcome Skunder | |
Descriptive Information | |
Judul Penelitian Popular | Bioequivalence Study of 15 mg Pioglitazone & 500 mg Metformin Tablets Manufactured by PT. Dankos Farma (Pionix M 500) in Comparison with Metact® Combination Tablets LD 15/500 Manufactured by Teva Takeda Pharma Ltd., Japan |
Judul Penelitian Ilmiah | Bioequivalence Study of 15 mg Pioglitazone & 500 mg Metformin Tablets Manufactured by PT. Dankos Farma (Pionix M 500) in Comparison with Metact® Combination Tablets LD 15/500 Manufactured by Teva Takeda Pharma Ltd., Japan |
Jenis Penelitian | Interventional |
Intervensi | Pionix M 500 |
Jumlah Subyek Penelitian | 24 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: Subjects had read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/procedures, Subjects healthy male and female, Subjects age range from 18 – 55 years, Subjects’ Body Mass Index (BMI) between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following range : Systolic blood pressure: 90 – 129 mmHg, Diastolic blood pressure: 60 – 84 mmHg, Pulse/Heart rate: 60 – 100 beats per minute, Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screeningExclusion Criteria: those who were pregnant and/or nursing condition, those with a history of hypersensitivity or contraindication to pioglitazone or metformin, or allied drugs, 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 pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric/intestine surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, those who had history or presence of any coagulation disorder or clinically significant hematology abnormalities, those who had history or presence of diabetes mellitus, those who disagreed to use contraception (condom) during intercourse with subjects’ spouse within study period, those who using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics of the study drug, within one week prior to the drug administration day, those who participated in any clinical study within the past 90 days prior to the study, those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study, those who had smoking habit more than 10 cigarettes a day, those who had history of travelling to another city within the last 14 days without following health authority regulation, those who had history of direct contact with a COVID-19 positive person in the subject’s neighborhood within the last 5 days, those who had history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days, those who were positive result for SARS CoV-2 swab antigen test, those who were positive result for HIV, HbsAg, and HCV tests (to be kept confidential),those who had history of drug or alcohol abuse within 12 months prior to screening for this study |
Administrative Information | |
Nomor Persetujuan Etik | KET-595/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 | 546/STD/PML/2020 |
Contact Person | Nabila Mudin S |