Bioequivalence study of cefixime 100 mg/5 mL dry syrup produced by PT Dexa Medica in comparison with the comparator drug (Suprax® 100 mg/5 mL Powder for Oral Suspension, Odan Laboratories Ltd., Canada)
Tahapan Penelitian : Complete
Sponsor:
PT Dexa Medica
Mitra Pelaksana:
PT Equilab International
No Registry
INA-W48WO2
Tanggal Input Registry : 14-03-2022
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 26-07-2021 |
| Outcome Primer | To find out whether the bioavailability of cefixime 100 mg/5 mL dry syrup produced by PT Dexa Medica is equivalent to that of the comparator drug (Suprax® 100 mg/5 mL Powder for Oral Suspension, Odan Laboratories Ltd., Canada). |
| Outcome Skunder | NA |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of cefixime 100 mg/5 mL dry syrup produced by PT Dexa Medica in comparison with the comparator drug (Suprax® 100 mg/5 mL Powder for Oral Suspension, Odan Laboratories Ltd., Canada) |
| Judul Penelitian Ilmiah | Bioequivalence study of cefixime 100 mg/5 mL dry syrup produced by PT Dexa Medica in comparison with the comparator drug (Suprax® 100 mg/5 mL Powder for Oral Suspension, Odan Laboratories Ltd., Canada) |
| Jenis Penelitian | Interventional |
| Intervensi | Test drug : Cefixime 100 mg/5 mL dry syrup produced by PT Dexa Medica. Reference drug : Suprax® 100 mg/5 mL Powder for Oral Suspension, Odan Laboratories Ltd., Canada, Imported by PT Dexa Medica. The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
| Jumlah Subyek Penelitian | 24 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. willing to provide written informed consent to participate in the study. 2. Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values. 3. Aged 18 – 55 years. 4. Preferably non-smokers or smoke less than 10 cigarettes each day. 5. Body mass index within 18 to 25 kg/m2. 6. Vital signs (after 10 minute rest) must be within the following ranges: - Systolic blood pressure : 100 – 129 mmHg - Diastolic blood pressure : 60 – 84 mmHg - Pulse rate : 60 – 90 bpmExclusion Criteria: 1. History of allergy or hypersensitivity or contraindication to cefixime or allied drug. 2. Pregnant or lactating female 3. Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illness. 4. Presence of any clinically significant abnormal values during screening 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV. 6. Reactive result for COVID-19 rapid antigen test (this criteria will only be applied if the study conduct during pandemic condition). 7. Clinically significant hematology abnormalities. 8. Clinically significant electrocardiogram (ECG) abnormalities. 9. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug 10. Past history of anaphylaxis or angioedema. 11. History of drug or alcohol abuse within 12 months prior to screening for this study. 12. Participation in any clinical trial within the past 90 days 13. History of any bleeding or coagulative disorders. 14. Presence of difficulty in accessibility of veins in left or right arm. 15. A donation or significant blood loss within 90 days 16. Intake of any prescription (especially cefixime or ofloxacin), non-prescription drug, food supplements or herbal medicines within 21 days |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-549/UN2.F1/ETIK/PPM.00.02/2021 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | BE. 398/EQL/2015 |
| Contact Person | Liana Wijaya, MBiomed., Kartika Widyanty |