Bioequivalence Study of 5 mg Desloratadine Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Aerius® 5 mg Film Coated Tablets Manufactured by Schering-Plough Labo N.V, Belgium, Registered by PT. Merck Sharp Dohme Pharma Tbk, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Clinisindo Laboratories
No Registry
-
Tanggal Input Registry : 04-02-2025

15-02-2018
AUC0-t , AUC0-inf , Cmax
Tmax, t1/2
 
Bioequivalence Study of 5 mg Desloratadine Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Aerius® 5 mg Film Coated Tablets Manufactured by Schering-Plough Labo N.V, Belgium, Registered by PT. Merck Sharp Dohme Pharma Tbk, Indonesia
Bioequivalence Study of 5 mg Desloratadine Film Coated Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Aerius® 5 mg Film Coated Tablets Manufactured by Schering-Plough Labo N.V, Belgium, Registered by PT. Merck Sharp Dohme Pharma Tbk, Indonesia
Interventional
Desloratadine Tablet 5 mg manufactured by PT Novell Pharmaceutical Laboratories
26
 

Inclusion Criteria:

1. Healthy subjects, both sexes, age between 18 to 55 years old 2. Weight with the normal range according to accepted normal values for the Body Mass Index (BMI = 18-25 kg/m2) 3. Accepted normal values of blood pressure (systolic blood pressure 90 mmHg, diastolic blood pressure 60 mmHg) and heart rate (60-90 bpm) 4. Gave a written informed consent 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, fasting glucose, total cholesterol, 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. Acceptable electrocardiogram (ECG) result. Initial ECG would be required from subjects who had never participated in BA/BE study at Clinisindo. ECG would be required every six months from subjects who have previously participated in a BA/BE study at Clinisindo.* 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 (would be done for female 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) could be accepted. 2. Pregnant woman or nursing mother. 3. Had history of hepatic, cardiovascular, gastrointestinal and renal disease. 4. Had a moderate to severe hepatic or renal dysfunction.(3,4,5) 5. Potentially hypersensitive to desloratadine or related medication such as loratadine.(3,4,5) 6. History of alcohol, drug abuse within 12 months prior to screening for this study. 7. Received any other medications within fourteen days prior to the start of the study, especially inhibitors of CYP 3A4 (such as ketoconazole, erythromycin and azithromycin), fluoxetine and cimetidine.(3) 8. Participated in any clinical study within 3 months after the date of completion. 9. Donation or loss more than 450 mL of blood within 3 months prior to the screening of the study.
 
857/UN2.F1/ETIK/2017
Not applicable
PPUK/PPUB number
Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com