Bioequivalence Study of 20 mg Tadalafil Orally Disintegrating Film Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Cialis® 20 mg Film Coated Tablets Manufactured by Lilly Del Caribe Inc., Puerto Rico, USA, Packed by Lilly S.A., Spain, Registered by PT. Pyridam Farma Tbk., Indonesia
| 1. Background | |
|---|---|
| Registration Number | |
| Date of registry approval | |
| Registration Date | 05-06-2025 |
| Secondary identifiers | No |
| Name of issuing authority (for example protocol number, other registries, etc) | |
| Secondary identifier number | |
| Scientific study title | Bioequivalence Study of 20 mg Tadalafil Orally Disintegrating Film Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Cialis® 20 mg Film Coated Tablets Manufactured by Lilly Del Caribe Inc., Puerto Rico, USA, Packed by Lilly S.A., Spain, Registered by PT. Pyridam Farma Tbk., Indonesia |
| Public (popular study title) | Bioequivalence Study of 20 mg Tadalafil Orally Disintegrating Film Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in Comparison with Cialis® 20 mg Film Coated Tablets Manufactured by Lilly Del Caribe Inc., Puerto Rico, USA, Packed by Lilly S.A., Spain, Registered by PT. Pyridam Farma Tbk., Indonesia |
| 2. Sponsor and Funding | |
| Primary Sponsor | PT. Novell Pharmaceutical Laboratories |
| Source(s) of monetary or material support | PT. Novell Pharmaceutical Laboratories |
| Other partners | PT Clinisindo Laboratories |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Prof. Dr. apt Yahdiana Harahap, MS |
| City | Jakarta Selatan |
| Country | Indonesia |
| Principal investigator's affiliation | PT Clinisindo Laboratories |
| Principal Investigator's email address | Yahdiana03@yahoo.com |
| Public Queries | |
| Contact person name for public queries | Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com |
| Address for public queries | Apt. Windy Lusthom, S.Si – Study Director PT Clinisindo Laboratories Jl. Ulujami Raya No.12, Pesanggrahan, Jakarta Selatan 12250, Indonesia Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com |
| City | Jakarta Selatan |
| Country | Indonesia |
| ZIP | 12250 |
| Affiliation for public queries | PT Clinisindo Laboratories |
| Email address for public queries | Apt. Windy Lusthom, S.Si – Study Director e-Mail: Windy.Lusthom@clinisindo.com |
| Phone number for public queries | (62-21) 73889918 |
| Scientific Queries | |
| Name of Contact for scientific queries | Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com |
| Address for scientific queries | Apt. Windy Lusthom, S.Si – Study Director PT Clinisindo Laboratories Jl. Ulujami Raya No.12, Pesanggrahan, Jakarta Selatan 12250, Indonesia Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com |
| City | Jakarta Selatan |
| Country | Jakarta Selatan Indonesia |
| ZIP | 12250 |
| Affiliation of scientific queries contact | PT Clinisindo Laboratories |
| Email address for scientific queries | e-Mail: Windy.Lusthom@clinisindo.com |
| 4. IRB & Regulatory | |
| Ethical Approval number | KET-1347/UN2.F1/ETIK/PPM.00.02/2023 |
| Name of Ethics committee | Komite Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Indonesia –RSUPN Dr. Cipto Mangunkusumo |
| Date of Ethic approval | 09-10-2023 |
| Contact details of Ethic Committee (phone, email, and office) | Komite Etik FKUI/RSCM Jl. Salemba 6, Jakarta Pusat Whatsapp : 0856-8701-608 Telp. 021 315 7008 E-mail :ec_fkui@yahoo.com |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | RG.01.02.321.05.24.02608/UB |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | PT Clinisindo Laboratories |
| Recruitment status | Complete |
| Date of first enrollment | 27-05-2024 |
| Targeted Sample size | 00024- |
| Number of enrolled participants | 25 |
| Date of study completion (last participant, last visit) | 14-06-2024 |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | Study in healthy human volunteers |
| Purpose of the study | Bioequivalence study |
| Study type | Interventional |
| Interventional Study category | Bioequivalence study |
| Method of allocation | |
| Description of the allocation concealment mechanism and sequence generation | |
| Masking | |
| Study intervention (study arm) | 20 mg Tadalafil Orally Disintegrating Film Produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories |
| Control intervention (control arm) | Cialis® 20 mg Film Coated Tablets Manufactured by Lilly Del Caribe Inc., Puerto Rico, USA, Packed by Lilly S.A., Spain, Registered by PT. Pyridam Farma Tbk., Indonesia |
| Intervention assignment | Crossover |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Not specified |
| Minimum age | 18 |
| Maximum age | 55 |
| Inclusion criteria | 1. Memberikan persetujuan tertulis
2. Subjek sehat, laki-laki, usia antara 18 hingga 55 tahun 3. Berat badan dalam rentang normal Indeks Masa Tubuh (BMI = 18 - 25 kg/m2) 4. Nilai tekanan darah normal yang diterima* 5. Tekanan darah sistolik 90 mmHg 6. Tekanan darah diastolik 60 mmHg 7. Detak jantung (60 - 90 bpm) 8. Riwayat medis dan pemeriksaan fisik yang dapat diterima 9. Nilai hematologi normal meliputi : hemogglobin, hematokrit, eritrosit, leukosit, nilai mean corpuscular (MC), diferensial leukosit, jumlah trombosit, dan laju sedimentasi eritrosit (ESR) * 10. Pemeriksaan laboratorium normal meliputi : sGPT, sGOT, alkaline phospatase, total bilirubin, total protein, albumin, globulin, glukosa darah, nitrogen urea darah, ureum, kreatinin, total kolesterol dan trigliserida * 11. Hasil urinalisis normal meliputi : warna, kejernihan, berat jenis, pH, leukosit esterase, nitrit, glukosa, keton, urobilinogen, bilirubin, sedimen darah dan urin (sel, gips, dan bakteri).* 12. Fungsi kardiovaskular normal dibuktikan dengan hasil elektrokardiogram (EKG). 13. Hasil negatif untuk tes serologi antigen hepatitis B (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV). 14. Hasil negatif untuk uji penyalahgunaan obat amfetamin, metamfetamin, morfin, mariyuana/tetrahidrokanabinol (THC), dan benzodiazepin 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, prokok ringan ( ≤5 batang/hari) dapat diterima.
2. Memiliki riwayat penyakit hati, kardiovaskular, gastrointestinal atau ginjal. 3. Memiliki riwayat atau konsisi penyakit jantung koroner (1,2) 4. Memiliki riwayat atau kondisi angina tidak stabil atau angina yang terjadi saat berhubungan intim (1,2) 5. Memiliki riwayat atau kondisi gagal jantung New York Hearth Association kelas 2 atau lebih (1,2) 6. Memiliki riwayat atau kondisi aritmia yang tidak terkontrol, hipotensi ( |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | AUC0-t , AUC0-inf , Cmax |
| Metric/method of measurement | Statistical analysis with Anova using Microsoft® Excel 2010, SAS® version 9.1 |
| Timepoint(s) of measurement | pre dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, and 72 hours after drug administration |
| Secondary outcome 1 | |
| Name of secondary outcome 1 (SO1) | tmax, t1/2 |
| Metric/method of measurement (SO1) | Statistical analysis with Anova using Microsoft® Excel 2010, SAS® version 9.1 |
| Timepoint(s) of measurement (SO1) | pre dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, and 72 hours after drug administration |
| 9. Study Results | |
| Brief summary of study results | In this study, the intra-subject CV of tadalafil for AUC0-72h was 15.81%. Thus, the sample size N=24 in this study was still sufficient in order to conclude bioequivalence with a power of 80% at the 5% nominal level
In conclusion, the application of parametric and non-parametric statistics revealed the presence of bioequivalence between 20 mg Tadalafil orally disintegrating film produced by PT. Etercon Pharma for PT. Novell Pharmaceutical Laboratories in comparison with Cialis® 20 mg film coated tablets manufactured by Lilly Del Caribe Inc., Puerto Rico, USA, packed by Lilly S.A., Spain, registered by PT. Pyridam Farma Tbk., Indonesia. Thus, it can be assumed that the two formulations were therapeutically equivalent and therefore interchangeable |
| Date of results summaries | 19-08-2024 |
| Participant flow | 37 Subjek mengikuti kegiatan skrining
25 Subjek enrolled 24 subjek mengikuti kegiatan sampling |
| Baseline characteristic | |
| Adverse events | hypotension and bradycardia |
| Outcome measures | The 90% Confidence Interval (CI) with α = 5.00% for AUC0-inf, AUC0-24h and Cmax were within the range of 80.00 - 125.00% interval |
| 10. Publication | |
| URL hyperlink(s) related to results and publications | |
| IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD)) | No |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | - |