Bioequivalence study of cefixime 100 mg capsule produced by PT IFARS Pharmaceutical Laboratories (Helixim® 100 Capsule) in comparison with the comparator drug (Cefspan® 100 mg Capsule, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan)
Tahapan Penelitian : Complete
Sponsor:
PT Ifars Pharmaceutical Laboratories
Mitra Pelaksana:
PT Equilab International
No Registry
INA-07C3WWP
Tanggal Input Registry : 22-04-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 28-12-2023 |
| Outcome Primer | AUC0-t dan Cmax |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of cefixime 100 mg capsule produced by PT IFARS Pharmaceutical Laboratories (Helixim® 100 Capsule) in comparison with the comparator drug (Cefspan® 100 mg Capsule, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan) |
| Judul Penelitian Ilmiah | Bioequivalence study of cefixime 100 mg capsule produced by PT IFARS Pharmaceutical Laboratories (Helixim® 100 Capsule) in comparison with the comparator drug (Cefspan® 100 mg Capsule, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan) |
| Jenis Penelitian | Interventional |
| Intervensi | The participating subjects were required to have an overnight fast and in the next morning (first day of each period) were given orally one test drug (cefixime 100 mg capsule produced by PT IFARS Pharmaceutical Laboratories) or one comparator drug (Cefspan® 100 mg Capsule, produced by PT Dankos Farma, for PT Kalbe Farma Tbk., Indonesia, under license of Otsuka Chemical Co., Ltd., Japan) with approximately 200 mL of water at ambient temperature. |
| Jumlah Subyek Penelitian | 20 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Able to participate, communicate well with the investigators and would 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 on laboratory evaluation, medical history or physical examination during the screening and could be considered healthy based on the evaluation, 3. Aged 18-55 years inclusive, 4. Preferably non-smokers or smoke less than 10 cigarettes per day, 5. Body mass index within 18 to 25 kg/m2, 6. Vital signs (after 10 minutes rest) were within the following ranges: • Systolic blood pressure : 100 – 129 mmHg • Diastolic blood pressure : 60 – 84 mmHg • Pulse rate : 60 – 90 bpm, 7. Willing to practice abstention or non-hormonal contraception during the study.Exclusion Criteria: 1. History of allergy or hypersensitivity or contraindication to cefixime or penicillin or allied drugs, 2. Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug), 3. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness, 4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc, 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV, 6. Clinically significant hematology abnormalities, 7. Clinically significant electrocardiogram (ECG) abnormalities, 8. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery, 9.Past history of anaphylaxis or angioedema, 10.History of drug or alcohol abuse within 12 months prior to screening for this study, 11.Participation in any clinical trial within the past 90 days calculated from the last visit to this study’s first dosing day, 12.History of any bleeding or coagulative disorders, 13.Presence of difficulty in accessibility of veins in left or right arm, 14.A donation or significant blood loss within 90 days before this study’s first dosing day, 15.Intake of any prescription (especially cefixime and ofloxacin), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-1637/UN2.F1/ETIK/PPM.00.02/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | BE. 646/EQL/2020 |
| Contact Person | Ronal Simanjuntak – PT Equilab International |