Bioequivalence study of Pysolan (30 mg Lansoprazole) delayed release capsule produced by PT Pyridam Farma in comparison with Takepron (30 mg Lansopazole) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd.
Tahapan Penelitian : Complete
Sponsor:
PT Pyridam Farma
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-R2CYB06
Tanggal Input Registry : 24-03-2022
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 03-02-2022 |
| Outcome Primer | AUC0-t dan Cmax |
| Outcome Skunder | AUC0-∞, t1/2, dan tmax |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Pysolan (30 mg Lansoprazole) delayed release capsule produced by PT Pyridam Farma in comparison with Takepron (30 mg Lansopazole) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd. |
| Judul Penelitian Ilmiah | Bioequivalence study of Pysolan (30 mg Lansoprazole) delayed release capsule produced by PT Pyridam Farma in comparison with Takepron (30 mg Lansopazole) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd. |
| Jenis Penelitian | Interventional |
| Intervensi | The reference drug was the market available Takepron (30 mg Lansopazole) delayed release capsule manufactured by Takeda Pharmaceutical Company Ltd, batch number AA1111 expiration date on February 2022. The test drug was Pysolan (30 mg Lansoprazole) delayed release capsule produced by PT Pyridam Farma, batch number PEPYS002.01-01; manufacturing date on October 2021; expiration date on October 2023. |
| Jumlah Subyek Penelitian | 36 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: - Willing to sign the informed consent. - Age 18 – 55 years, - Body mass index between 18 – 25 kg/m2 - Normotensive ((systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 6080 mmHg), heart rate 60 – 90 beats per minute, - Healthy male (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 examinationExclusion Criteria: - Who is contraindicated or had history of hypersensitivity to lansoprazole or 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 months 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 - If the study is conducted in Covid-19 pandemic situation, the exclusions criteria bellow must be applied: a. Those with history of direct contact with Covid-19 positive person within last 14 days b. Those with history or present sore throat, fever (with temperature more than 37oC) or short of breath within last 14 days c. Those who are positive to Covid-19 antigen rapid test |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-1233/UN2.F1/ETIK/PPM.00.02/2021 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 139/FORM/OMF/2021 |
| Contact Person | apt. Haranissa Dea Oktania |