Bioequivalence Study of Lapraz® Delayed-Release Capsule (Lansoprazole 30 mg) Manufactured by PT Sanbe Farma in comparison with Takepron® Delayed-Release Capsule (Lansoprazole 30 mg) Manufactured by Teva Takeda Pharmaceutical Company Limited, Japan in Healthy Subjects
Tahapan Penelitian : Complete
Sponsor:
PT SANBE FARMA
Mitra Pelaksana:
Not Specified
No Registry
INA-04W2TW1C
Tanggal Input Registry : 07-04-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 05-12-2024 |
| Outcome Primer | Cmax, AUC0-t |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of Lapraz® Delayed-Release Capsule (Lansoprazole 30 mg) Manufactured by PT Sanbe Farma in comparison with Takepron® Delayed-Release Capsule (Lansoprazole 30 mg) Manufactured by Teva Takeda Pharmaceutical Company Limited, Japan in Healthy Subjects |
| Judul Penelitian Ilmiah | Bioequivalence Study of Lapraz® Delayed-Release Capsule (Lansoprazole 30 mg) Manufactured by PT Sanbe Farma in comparison with Takepron® Delayed-Release Capsule (Lansoprazole 30 mg) Manufactured by Teva Takeda Pharmaceutical Company Limited, Japan in Healthy Subjects |
| Jenis Penelitian | Interventional |
| Intervensi | Penelitian dilakukan secara komparatif pada subjek sehat dengan desain acak (randomized), double-blind, three-period, partial reference-replicated three-way crossover menggunakan Takepron® Kapsul Lepas Tunda (Lansoprazole 30 mg) sebagai obat komparator dan sampel plasma untuk pengujian |
| Jumlah Subyek Penelitian | 27 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: - Voluntary agree to sign informed consent. - Male and female subjects aged between 18–50 years. - Normal body weight (Body Mass Index/BMI :18–25 kg/m2). - Have healthy conditions based on the results of physical examination, clinical/laboratory test, and medical history. - Normal blood pressure (90–129 mmHg for systolic and 60–84 mmHg for diastolic). - Normal pulse rate (60–100 bpm). - Normal respiratory rate (12–20 times/minute). - Normal body temperature (≤37oC). - Normal result of 12-lead ECG.Exclusion Criteria: - History of hypersensitivity to lansoprazole or other proton-pump inhibitor drugs. - Heavy smoker (smoke >10 cigarettes/day). - Pregnant woman. - Breastfeeding woman. - Alcohol and/or drug abuse. - Any surgical or medical condition (present or history) which may significantly alter drug absorption, e.g., gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. - Impaired liver and renal function. - Serologically positive for HBsAg, anti-HCV, and anti-HIV during health screening. - A donation or blood loss of 300 mL (or more) within 90 days prior to drug administration. - Participation in any other bioequivalence study or clinical study within the past 90 days prior to drug administration. - Consumption of any other medicines within one week prior to drug administration. - Consumption of alcohol, coffee, tea, chocolate, cola, fruit juice, or carbonated drinks and smoking within 24 hours prior to drug administration. - Positive COVID-19 antigen rapid test result for prospective subjects who had not received a booster vaccine and/or subjects who experience COVID-19 symptoms. |
| Administrative Information | |
| Nomor Persetujuan Etik | 51/UN6.KEP/EC/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | PRO-01/2024/SCQ Rev. 01 |
| Contact Person | Nanda Lestari, S.Si, Apt. |