Bioequivalence Study of Meloxicam 15 mg Tablet Manufactured by PT Combiphar in Comparison with Movicox(R) 15 mg Tablet Manufactured by PT. Boehringer Ingelheim Indonesia.
Tahapan Penelitian : Complete
Sponsor:
PT Combiphar
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-BFL2BY1
Tanggal Input Registry : 29-07-2024
Tracking Information | |
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Tanggal Antisipasi Studi | 18-01-2019 |
Outcome Primer | AUC0-t , Cmax |
Outcome Skunder | AUC0-inf , Tmax, Half life |
Descriptive Information | |
Judul Penelitian Popular | Bioequivalence Study of Meloxicam 15 mg Tablet Manufactured by PT Combiphar in Comparison with Movicox(R) 15 mg Tablet Manufactured by PT. Boehringer Ingelheim Indonesia. |
Judul Penelitian Ilmiah | Bioequivalence Study of Meloxicam 15 mg Tablet Manufactured by PT Combiphar in Comparison with Movicox(R) 15 mg Tablet Manufactured by PT. Boehringer Ingelheim Indonesia. |
Jenis Penelitian | Interventional |
Intervensi | Meloxicam 15 mg Tablet |
Jumlah Subyek Penelitian | 14 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: The inclusion criteria were healthy male or female who: had read the subject information and signed informed consent documents, were age between 18 – 55 years , had body mass index (BMI) between 18–25 kg/m2, had a normal electrocardiogram, had a normal blood pressure (systolic was ranged between 90 – 120 mmHg and diastolic was 60 – 80 mmHg), had normal heart rate (ranged between 60 to 100 bpm), had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.Exclusion Criteria: Subject who were excluded from the study: those who were pregnant and/or nursing woman, those with a history of hypersensitivity to meloxicam, or otr other NSAID, or other ingredients in the drugs or a history of serious allergic reaction to any drug, 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 surgery, renal insufficiency, hepatic dysfunction or any 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 participate in any clinical study within 3 months 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 smoked, those who were positive to HIV, HbsAg, and HCV tests (to be kept confidential), those with a history of drug or alcohol abuse within 12 months prior to screening for this study, those who were unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access. |
Administrative Information | |
Nomor Persetujuan Etik | 1092/UN2.F1/ETIK/2018 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
Other Study ID Numbers | |
Contact Person | Merry Christianie |