Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule Manufactured by PT IFARS Pharmaceutical Laboratories (Dobrizol Delayed-Release Capsule) in Comparison with 30 mg Takepron® Delayed-Release Capsule Manufactured by Takeda Teva Pharmaceuticals Company Limited, Japan.
Tahapan Penelitian : Complete
Sponsor:
PT IFARS Pharmaceutical Laboratories
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-YYAG360
Tanggal Input Registry : 04-08-2022
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 28-01-2022 |
| Outcome Primer | To investigate whether 30 mg Lansoprazole delayed-release capsule manufactured by PT IFARS Pharmaceutical Laboratories (Dobrizol Delayed-Release Capsule) is bioequivalent to its reference product, 30 mg Takepron® delayed-release capsule manufactured by Takeda Teva Pharmaceuticals Company Limited, Japan. |
| Outcome Skunder | N/A |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule Manufactured by PT IFARS Pharmaceutical Laboratories (Dobrizol Delayed-Release Capsule) in Comparison with 30 mg Takepron® Delayed-Release Capsule Manufactured by Takeda Teva Pharmaceuticals Company Limited, Japan. |
| Judul Penelitian Ilmiah | Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule Manufactured by PT IFARS Pharmaceutical Laboratories (Dobrizol Delayed-Release Capsule) in Comparison with 30 mg Takepron® Delayed-Release Capsule Manufactured by Takeda Teva Pharmaceuticals Company Limited, Japan. |
| Jenis Penelitian | Interventional |
| Intervensi | Subjects were given a single dose of 30 mg lansoprazole of either formulation (test or reference) with 240 ml of water |
| Jumlah Subyek Penelitian | 35 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: The inclusion criteria were healthy male or female subjects who/with: -had read the subject information and signed informed consent documents -age range from 18 – 55 years -body mass index between 18–25 kg/m2 -had a normal electrocardiogram -had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg) -had the heart rate within normal range (60 – 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: This study was excluded to: -those who were pregnant and/or nursing women (for women). -those with history of contraindication or hypersensitivity to Lansoprazole, or other proton pump inhibitor drugs or other ingredients in the drugs 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 pharmacokinetic 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-1052/UN2.F1/ETIK/PPM.00.02/2021 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 612/STD/PML/2021 |
| Contact Person | Nabila Mudin S |