Bioequivalence Study of 500 mg Clarithromycin XR Extended Release Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Abbotic® XL 500 mg Modified Release Film Coated Tablets Produced by PT. Abbot Indonesia.
Tahapan Penelitian : Complete
Sponsor:
PT. Novell Pharmaceutical Laboratories
Mitra Pelaksana:
PT. Clinisindo Laboratories
No Registry
Tanggal Input Registry : 17-04-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 05-10-2022 |
| Outcome Primer | The application of parametric and non-parametric statistics reveals the presence of bioequivalence 500 mg Clarithromycin XR Extended Release Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in comparison with Abbotic® XL 500 mg Modified Release Film Coated Tablets Produced by PT. Abbot Indonesia. Thus it can be assumed that the two formulations were therapeutically equivalent and therefore interchangeable. |
| Outcome Skunder | The application of parametric and non-parametric statistics reveals the presence of bioequivalence 500 mg Clarithromycin XR Extended Release Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in comparison with Abbotic® XL 500 mg Modified Release Film Coated Tablets Produced by PT. Abbot Indonesia. Thus it can be assumed that the two formulations were therapeutically equivalent and therefore interchangeable. |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 500 mg Clarithromycin XR Extended Release Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Abbotic® XL 500 mg Modified Release Film Coated Tablets Produced by PT. Abbot Indonesia. |
| Judul Penelitian Ilmiah | Bioequivalence Study of 500 mg Clarithromycin XR Extended Release Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Abbotic® XL 500 mg Modified Release Film Coated Tablets Produced by PT. Abbot Indonesia. |
| Jenis Penelitian | Interventional |
| Intervensi | The reference drug was the market available Abbotic® XL 500 mg Modified Release Film Coated Tablets (Produced by PT. Abbot Indonesia) batch number 28724XP; manufacturing date Mei 2021; expiration date Mei 2023. The test drug was Clarithromycin XR Extended Release Film Coated Tablets produced by PT Novell Pharmaceutical Laboratories, batch number D21I04 manufacturing date Oktober 2021; expiration date September 2023. In the sampling day, each subject received a single oral dose of 500 mg Clarithromycin, either as test or reference formulation administered along with 220 mL of water. The dose was taken at 07.00 am after an overnight fast for at least 8 hours. Water intake was allowed except for one hour before and one hour after the dose. |
| Jumlah Subyek Penelitian | 36 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Memberikan persetujuan tertulis. 2. Subyek sehat, laki-laki atau perempuan, usia antara 18 sampai 55 tahun. 3. Berat badan dalam rentang normal Indeks Masa Tubuh (BMI = 18-25 kg/m2). 4. Nilai tekanan darah normal yang diterima : - Tekanan darah sistolik 90 mmHg - Tekanan darah diastolik 60 mmHg) - Detak jantung (60-90 bpm). 5. Riwayat medis dan pemeriksaan fisik yang dapat diterima. 6. Nilai hematologi normal meliputi : hemoglobin, hematokrit, eritrosit, leukosit, nilai mean corpuscular (MC), diferensial leukosit, jumlah trombosit dan laju sedimentasi eritrosit (ESR).* 7. Pemeriksaan laboratorium normal meliputi : sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, glukosa darah, nitrogen urea darah, ureum, kreatinin.* 8. Hasil urinalisis normal meliputi : warna, kejernihan, berat jenis, pH, leukosit esterase, nitrit, glukosa, keton, urobilinogen, bilirubin, sedimen darah dan urin (sel, gips, dan bakteri).* 9. Fungsi kardiovaskular normal dibuktikan dengan hasil elektrokardiogram (EKG). 10. Hasil negatif untuk tes serologi antigen hepatitis B (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV). 11. Hasil negatif untuk uji penyalahgunaan obat amfetamin, metamfetamin, morfin, mariyuana/tetrahidrokanabinol (THC), dan benzodiazepin. 12. Hasil tes kehamilan negatif (akan dilakukan skrining, sebelum penelitian periode I dan sebelum penelitian periode II). 13. Hasil tes antigen cepat COVID-19 (Coronavirus) negatif selama pandemi COVID-19 (dilakukan untuk semua subjek pada saat skrining, sebelum periode I dan sebelum periode II penelitian). Catatan : Penyelidik klinis mungkin memasukkan subjek yang memiliki nilai di luar rentang yang diterima, jika menurut pendapatnya, nilai ini tidak signifikan secara klinis.Exclusion Criteria: 1. Perokok. Jika perlu, perokok ringan (≤5 batang/hari) dapat diterima. 2. Memiliki riwayat penyakit hati, kardiovaskular, gastrointestinal atau ginjal. 3. Memiliki riwayat perpanjangan QT (perpanjangan QT kongenital atau didapat) atau aritmia jantung ventrikel, termasuk torsade de pointes. 4. Mengalami gangguan elektrolit (hipokalemia atau hipomagnesemia). 5. Riwayat alkohol, penyalahgunaan obat dalam 12 bulan sebelum skrining untuk penelitian ini. 6. Menerima obat lain dalam waktu empat belas hari sebelum dimulainya penelitian. 7. Berpartisipasi dalam studi klinis apa pun dalam waktu 3 bulan setelah tanggal penyelesaian. 8. Donasi atau kehilangan lebih dari 300 mL darah dalam waktu 3 bulan sebelum pemeriksaan penelitian. 9. Hipersensitif terhadap klaritromisin atau makrolida lainnya atau agen antibakteri azalida. 10. Wanita hamil dan menyusui. 11. Hasil tes rapid antigen COVID-19 (Coronavirus) positif saat skrining, sebelum memulai periode I atau II. |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-95/UN2.FI/ETIK/PPM.00.02/2022 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | CCCXXX/213/CL/2021 |
| Contact Person | RA PT. Novell |