Bioequivalence Study of 100 mg Lamotrigine Tablets, Manufactured by PT. Pharos Indonesia (Lamiros®) in Comparison with the Innovator’s Tablets (Lamictal), Manufactured by GlaxoSmithKline Pharmaceuticals S.A, Poznan-Poland, Imported by PT. Glaxo Wellcome Indonesia, Jakarta-Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT Pharos Indonesia
Mitra Pelaksana:
Econolab
No Registry
INA-7D6TG52
Tanggal Input Registry : 07-02-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 04-06-2021 |
| Outcome Primer | AUC0-t and Cmax |
| Outcome Skunder | AUC0-t, Tmax, T1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 100 mg Lamotrigine Tablets, Manufactured by PT. Pharos Indonesia (Lamiros®) in Comparison with the Innovator’s Tablets (Lamictal), Manufactured by GlaxoSmithKline Pharmaceuticals S.A, Poznan-Poland, Imported by PT. Glaxo Wellcome Indonesia, Jakarta-Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence Study of 100 mg Lamotrigine Tablets, Manufactured by PT. Pharos Indonesia (Lamiros®) in Comparison with the Innovator’s Tablets (Lamictal), Manufactured by GlaxoSmithKline Pharmaceuticals S.A, Poznan-Poland, Imported by PT. Glaxo Wellcome Indonesia, Jakarta-Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Single dose of 100 mg Lamotrigine Tablets (Lamiros®) Manufactured by PT Pharos Indonesia |
| Jumlah Subyek Penelitian | 22 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Able to participate, communicate well with the investigators and agree to sign an informed consent; Willing to use contraception (condoms) when intercourse with spouse during the study; Healthy male or female subjects as determined by the medical screening assessments; Aged 18-55 years of age; Body mass index (BMI) is in the range of 18-25 kg/m²; Systolic blood pressure:100-120 mmHg; Diastolic blood pressure: 60-80 mmHg; Pulse rate 60-90 bpm; Normal electrocardiogram (ECG); Clinical laboratory results have to be within normal range. Medical judgement of responsible physician determined any laboratory finding beyond its standard value.Exclusion Criteria: Able to participate, communicate well with the investigators and agree to sign an informed consent; Willing to use contraception (condoms) when intercourse with spouse during the study; Healthy male subjects as determined by the medical screening assessments; Aged 18-55 years of age; Body mass index (BMI) is in the range of 18-25 kg/m²; Systolic blood pressure:100-120 mmHg; Diastolic blood pressure: 60-80 mmHg; Pulse rate 60-90 bpm; Normal electrocardiogram (ECG); Clinical laboratory results have to be within normal range. Medical judgement of responsible physician determined any laboratory finding beyond its standard value. |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-1265/UN2.F1/ETIK/PPM.00.02/2019 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | PRO-246/19/ECL |
| Contact Person | Ni Made Dwi Wulandari |