Bioequivalence Study of 400 mg Moxifloxacin (Moximox) Film Coated Caplets Produced by PT. Imedco Djaja in Comparison with Avelox 400 mg Film Coated Tablets Produced by Bayer AG, Germany, imported by PT. Bayer Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Clinisindo Laboratories
No Registry
INA-NCZR265
Tanggal Input Registry : 21-11-2022

03-06-2022
Parameter Pharmacokinetic (AUC0-t (ng.jam/mL), AUC0-∞(ng.jam/mL), Cmax (ng/mL), t1/2 (h), tmax)) dari obat uji (Moximox) dan Obat Pembanding (Avelox) Ratio Nilai Rata – Rata Geometrik (90%) CI dari AUC0-t (ng.jam/mL), AUC0-∞(ng.jam/mL), Cmax (ng/mL) obat uji (Moximox) dan Obat Pembanding (Avelox) %CV Intra subjek
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Bioequivalence Study of 400 mg Moxifloxacin (Moximox) Film Coated Caplets Produced by PT. Imedco Djaja in Comparison with Avelox 400 mg Film Coated Tablets Produced by Bayer AG, Germany, imported by PT. Bayer Indonesia
Bioequivalence Study of 400 mg Moxifloxacin (Moximox) Film Coated Caplets Produced by PT. Imedco Djaja in Comparison with Avelox 400 mg Film Coated Tablets Produced by Bayer AG, Germany, imported by PT. Bayer Indonesia
Interventional
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14
 

Inclusion Criteria:

1. Given a written consent. 2. Healthy subjects, both sexes age between 18 to 55 years old 3. Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18 – 25 kg/m2). 4. Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm). 5. Acceptable medical history and physical examination. 6. Normal hematology values including: hemoglobin, hematocrit, erythrocyte, leukocyte, mean corpuscular (MC) values, leukocyte differential, platelets count and erythrocyte sedimentation rate (ESR).* 7. Normal laboratory tests including: sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, albumin, globulin, blood glucose, blood urea nitrogen, ureum, creatinine.* 8. Normal urinalysis results including: color, clarity, specific gravity, pH, leukocyte esterase, nitrite, glucose, keton, urobilinogen, bilirubin, blood and urine sediments (cells, casts, and bacteria). * 9. Normal cardiovascular function proven by electrocardiogram (ECG) result. 10. Negative result for serological tests of hepatitis B antigen (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV). 11. Negative result for drug of abuse tests of amphetamine, metamphetamine, morphine, marijuana/tetrahydrocannabinol (THC), and benzodiazepine. 12. Negative result for pregnancy test (will be done for female subjects at screening, before period I and before period II of the study). 13. Negative result for rapid antigen test of COVID-19 (Coronavirus) during COVID19 pandemic (was done for all subjects at screening, before period I and before period II of the study). Note: * The clinical investigator might include a subject having value outside the accepted range, if in his/her opinion, these values were not clinically significant.

Exclusion Criteria:

1. Smoker. If necessary, light smoker (≤5 cigarettes/day) can be accepted. 2. Had history of hepatic, cardiovascular, gastrointestinal and renal disease. 3. Had history of tendon disease/disorder related to fluoroquinolones treatment. 4. Had congenital or documented acquired QT prolongation. 5. Had history of electrolyte disturbances, particularly hypokalemia. 6. Had history of clinically relevant bradycardia. 7. Had history of clinically relevant heart failure with left-ventricular ejection fraction. 8. Had history of symptomatic arrhythmias. 9. Had central nervous system disorders. 10. Had myasthenia gravis. 11. Had complicated pelvic inflammatory disease. 12. Had history or family history of glucose-6-phosphatase dehydrogenase deficiency. 13. Had galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 14. History of alcohol, drug abuse within 12 months prior to screening for this study. 15. Received any other medications within fourteen days prior to the start of the study. 16. Participated in any clinical study within 3 months after the date of completion. 17. Donation or loss more than 300 mL of blood within 3 months prior to the screening of the study. 18. Hypersensitivity to moxifloxacin or other fluoroquinolones. 19. Pregnant and breastfeeding women. 20. Positive result for rapid antigen test of COVID-19 (Coronavirus) at screening, before starting period I or II. Removal of Subjects from Therapy or Assessment 1. Withdrawal of consent. 2. Appearance during the trial of an exclusion criteria. 3. Vomiting event occurs at or before 2 times median tmax. 4. Serious Adverse Event (SAE) and Serious Adverse Drug Reaction (SADR). 5. Experiencing diarrhea during the period of blood sampling. 6. Noncompliance with study time table. 7. Noncompliance with study procedures. 8. Investigator’s decision in the best subject’s interest. In any case the subject withdrawal will be clearly reported and analyzed in CRF.
 
No. KET-443/UN2.F1/ETIK/PPM.00.02/2022
BE04-22 Version 1
Fitria Susiani