Bioequivalence Study of 500 mg Divalproex Sodium Extended Release Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Depakote ER 500 mg Extended Release Tablets Manufactured by PT. Abbott Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT. Novell Pharmaceutical Laboratories
Mitra Pelaksana:
PT. Clinisindo Laboratories
No Registry
INA-E3QOQ98
Tanggal Input Registry : 30-03-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 11-10-2022 |
| Outcome Primer | The primary objective of this study was to establish the bioequivalence of 500 mg Divalproex Sodium extended release tablets produced by PT. Novell Pharmaceutical Laboratories in comparison with Depakote ER 500 mg extended release tablets manufactured by PT. Abbott Indonesia. |
| Outcome Skunder | Tolerance assessment was not a major objective in this study. However, comparison of tolerance between the two products was a secondary objective. The criteria of safety would include any adverse reactions or significant abnormal laboratory values, or abnormal physical examinations or vital signs measurements recorded during the study. Any of these observations were documented in the subject’s Case Report Form (CRF). |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 500 mg Divalproex Sodium Extended Release Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Depakote ER 500 mg Extended Release Tablets Manufactured by PT. Abbott Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence Study of 500 mg Divalproex Sodium Extended Release Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Depakote ER 500 mg Extended Release Tablets Manufactured by PT. Abbott Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Tablet batch number 25418XP manufacturing date 1 February 2021, expiration date 1 February 2023. The test drug was Divalproex Sodium Extended Release FC Tablets produced by PT. Novell Pharmaceutical Laboratoirs, batch number D21E06 manufacturing date June 2021 , expiration date May 2023. In the sampling day, each subject received a single-oral dose of 500 mg Divalproex Sodium, 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 ar least 8 hours. Water intake was allowed except for one hour before and one hour after the dose |
| Jumlah Subyek Penelitian | 21 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1.Diberikan informed consent secara tertulis. 2.Subyek laki-lai dan perempuan sehat, usia 18-55 tahun. 3.Berat badan normal sesuai dengan Body Mass Index (BMI = 18-25 kg/m2) 4.Tekanan darah normal (sistolik 90 mmHg, diastolik 60 mmHg) dan denyut jantung (60-90 bpm) 5.Pemeriksaan fisik serta riwayat medis dapat diterima. 6.Pemeriksaan hematologi : hemoglobin, hematocrite, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR) hasil normal. 7.Pemeriksaan kimia darah laboratorium : sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine hasil normal. 8.Urinalisis termasuk warna, kejernihan, berat jenis, pH, leukosit esterase, nitrit, glucose, keton, urobilinogen, bilirubin, sedimen darah dan urine (cells, casts and bacteria) hasil normal. 9.Fungsi kardiovaskular yang normal dibuktikan dengan hasil elektrokardiogram (EKG). 10.Pemeriksaan tes serologi untuk antigen hepatitis B (HBsAg), Hepatitis C (Anti HCV) HIV ( anti HIV) hasil negatif. 11.Pemeriksaan drug abuse test terhadap amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), dan benzodiazepine hasil negatif. 12.Pemeriksaan hasil rapid tes COVID-19 (Coronavirus) selama pandemic COVID-19 (dilakukan untuk semua subjek pada saat skrining, sebelum periode I dan sebelum periode II penelitian) dengan hasil negatif 13.Hasil tes kehamilan negatif (dilakukan untuk subjek wanita pada saat skrining, sebelum setiap periode penelitian). 14.Subjek wanita bersedia menggunakan kontrasepsi jika melakukan hubungan seksual selama penelitian ini.Exclusion Criteria: 1.Perokok (>5 batang rokok per hari) 2.Memiliki penyakit hati atau disfungsi hati yang signifikan. 3.Memiliki gangguan mitokondria yang disebabkan oleh mutasi pada mitokondria DNA polimerase γ (POLG; misalnya Sindrom Alpers-Huttenlocher) 4.Berpotensi sensitif terhadap obat jenis ini atau hipersensitif terhadap natrium divalproex 5.Mengalami gangguan siklus urea 6.Mengalami porfiria 7.Wanita hamil dan wanita wanita usia subur yang tidak menggunakan metode kontrasepsi yang efektif selama pengobatan dengan valproate 8.Memiliki riwayat penyakit hati, kardiovaskular, gastrointestinal atau ginjal. 9.Riwayat alkohol, penyalahgunaan obat dalam 12 bulan sebelum skrining untuk penelitian ini. 10.Menerima pengobatan lain dalam 14 hari sebelum pengujian 11.Berpartisipasi dalam studi klinik 3 bulan sebelumnya 12.Pernah melakukan donor darah atau kehilangan darah lebih dari 300 mL sebelum studi |
| Administrative Information | |
| Nomor Persetujuan Etik | S-583/UN2.F1/ETIK/PPM.00.02/2022 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | CCCXVII/208/CL/2021 |
| Contact Person | Andre Rafela |