Bioequivalence Study of 10 mg Domperidone Orally Disintegrating Tablet, Manufactured by PT. Guardian Pharmatama (Galflux® ODT) in Comparison with the Innovator’s Film Coated Tablets (Motilium®), Manufactured by PT. Taisho Pharmaceutical Indonesia Tbk., Depok - Indonesia, Under License by Janssen Pharmaceutica, Beerse - Belgium, Division of Johnson & Johnson
Tahapan Penelitian : Complete
Sponsor:
PT Guardian Pharmatama
Mitra Pelaksana:
Econolab
No Registry
INA-PZAMXFD
Tanggal Input Registry : 07-02-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 12-06-2021 |
| Outcome Primer | AUC0-t and Cmax |
| Outcome Skunder | AUC0-t, Tmax, T1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 10 mg Domperidone Orally Disintegrating Tablet, Manufactured by PT. Guardian Pharmatama (Galflux® ODT) in Comparison with the Innovator’s Film Coated Tablets (Motilium®), Manufactured by PT. Taisho Pharmaceutical Indonesia Tbk., Depok - Indonesia, Under License by Janssen Pharmaceutica, Beerse - Belgium, Division of Johnson & Johnson |
| Judul Penelitian Ilmiah | Bioequivalence Study of 10 mg Domperidone Orally Disintegrating Tablet, Manufactured by PT. Guardian Pharmatama (Galflux® ODT) in Comparison with the Innovator’s Film Coated Tablets (Motilium®), Manufactured by PT. Taisho Pharmaceutical Indonesia Tbk., Depok - Indonesia, Under License by Janssen Pharmaceutica, Beerse - Belgium, Division of Johnson & Johnson |
| Jenis Penelitian | Interventional |
| Intervensi | Single dose of 10 mg Domperidone Orally Disintegrating Tablet (Galflux® ODT), Manufactured by PT Guardian Pharmatama |
| Jumlah Subyek Penelitian | 14 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Able to participate, communicate well with the investigators and agree to sign an informed consent; Willing to use contraception (condoms) when intercourse with spouse during the study; Healthy male/female subjects as determined by the medical screening assessments; Aged 18-55 years of age; Body mass index (BMI) is in the range of 18-25 kg/m²; Normal blood pressure (Systolic blood pressure:100-120 mmHg; Diastolic blood pressure: 70-80 mmHg; Pulse rate 60-90 bpm); Normal electrocardiogram (ECG); Clinical laboratory results have to be within normal range.Exclusion Criteria: Pregnant or lactating women (urinary pregnancy test to be applied to female subjects when screening and just before taking the test or innovator drug); Known hypersensitivity or contraindication to the study drug; intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within 7 days of this study’s first dosing day; History of any prior allergic drug rash; History of any bleeding or coagulation disorders; Any surgical or medical condition (present or history) which might significantly alters the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal diseases including gastric or duodenal ulcers or history of gastric surgery; A donation or loss of 300 mL (or more) of blood within 3 months before this study’s first dosing day; A positive Hepatitis B surface antigen (HBsAg), HCV, HIV test result; History of drug or alcohol abuse within 12 months prior to this study; Heavy Smoker (more than 10 cigarettes a day);Clinically have significant bleeding within 3 months prior to the study; Participation in a previous study within 3 months of this study’s first dosing day; A positive SARS-CoV2 (Covid-19) antigen rapid test result (Covid-19 antigen rapid test to be applied to all subjects when screening and one day before drug administration in each period of study). |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-328/UN2.F1/ETIK/PPM.00.02/2020 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | PRO-247/20/ECL |
| Contact Person | Ni Made Dwi Wulandari |