Bioequivalence Study of Carvedilol 25 mg Tablets Manufactured by PT. Kalbe Farma Tbk in Comparison with Dilatrend® 25 mg Tablets Manufactured by Delpharm Milano S.r.l., Via Varnevale, Segrate (MI), Italy under license of Cheplapharm Arzneimittel GmbH, Greifswald, Germany, Imported by DKSH Malaysia Sdn Bhd, Selangor Darul Ehsan, Malaysia.
Tahapan Penelitian : Complete
Sponsor:
PT. Kalbe Farma Tbk
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-48CBPT0
Tanggal Input Registry : 14-08-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 20-02-2022 |
| Outcome Primer | Cmax and AUCt |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Carvedilol 25 mg Tablets Manufactured by PT. Kalbe Farma Tbk in Comparison with Dilatrend® 25 mg Tablets Manufactured by Delpharm Milano S.r.l., Via Varnevale, Segrate (MI), Italy under license of Cheplapharm Arzneimittel GmbH, Greifswald, Germany, Imported by DKSH Malaysia Sdn Bhd, Selangor Darul Ehsan, Malaysia. |
| Judul Penelitian Ilmiah | Bioequivalence Study of Carvedilol 25 mg Tablets Manufactured by PT. Kalbe Farma Tbk in Comparison with Dilatrend® 25 mg Tablets Manufactured by Delpharm Milano S.r.l., Via Varnevale, Segrate (MI), Italy under license of Cheplapharm Arzneimittel GmbH, Greifswald, Germany, Imported by DKSH Malaysia Sdn Bhd, Selangor Darul Ehsan, Malaysia. |
| Jenis Penelitian | Interventional |
| Intervensi | Carvedilol 25 mg Tablet |
| Jumlah Subyek Penelitian | 50 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Subject had read the subject information and signed informed consent documents, Subject age range from 18 – 55 years, Subject body mass index between 18 – 25 kg/m2, Subject had a normal electrocardiogram, Subject had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg), Subject had the heart rate within normal range (60 – 100 bpm), Subject had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, Subject medical history or physical examination during screening, Subject agreed to use protection (condom) before any intercourse with their spouse during the studyExclusion Criteria: those who were pregnant and/or nursing women, those with history of contraindication or hypersensitivity to carvedilol or other β-adrenoreceptor blocking 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 pharmacokinetics 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-1107/UN2.F1/ETIK/PPM.00.02/2021 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | 636/STD/PML/2021 |
| Contact Person | Nabila Mudin S |