Allergy rhinitis Bioequivalence
Conditions
Interventions
Reference Product, desloratadine 5 mg film-coated tablet, will be given orally with 240 mL of ambient temperature drinking water.
No water and food for 1 hour and 4 hours, respectively, after dosing.
Active Comparator Drug,Active Comparator Drug
Sponsors
Macrophar Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Male and female, healthy volunteers aged 18-55 years, body mass index between 18.0 to 30.0 kg/m2. All of them should be able to complete the clinical study including the follow-up and capable of providing written informed consent.
Exclusion criteria
Exclusion criteria: 1 History of allergic reaction or hypersensitivity to desloratadine or any of the excipients of the product, 2 History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine, pulmonary or respiratory, cardiovascular, psychiatric, neurologic, allergic disease or any significant ongoing chronic medical illness, 3 Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID19, 4 History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period, 5 Family history or evidence of seizures, 6 History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, 7 History of problems with swallowing tablet or capsule, 8 History of sensitivity to heparin or heparin-induced thrombocytopenia, 9 Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy, 10 History of diarrhea within 24 hours prior to check-in in each period, 11 History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse, 12 12lead ECG demonstrating QTc more than 450 msec, a QRS interval more than 120 msec or with an abnormality considered clinically significant at screening, 13 Investigation with blood sample shows positive test for HBsAg, 14 Abnormal liver function, more than 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test, 15 Have renal creatinine clearance NMT 30 mL/min based on serum creatinine results, using glomerular filtration rate, at the screening laboratory test, 16 History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study, 17 History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women, 18 History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check in 19 History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study, 20 Consume or drink juice of grapefruit or orange or pomelo or its supplement/containing products and cannot abstain for at least 7 days prior to check in in Period 1 and continued for entire duration of the study, 21 Use of prescription or nonprescription drugs, herbal medications or supplements, vitamins or mineral or dietary supplements within 14 days prior to check-in in Period 1 and continued for entire duration of the study, 22 Participated in other clinical trials within 90 days prior to check-in in Period 1 (except for the subjects who drop out or withdrawn from the previous study prior to Period 1 dosing) or still participates in the clinical trial or participates in other clinical trials during enrollment in this study, 23 Blood donation or blood loss more than 1 unit within 90 days prior to check in in Period 1 or during enrollment, 24 Subjects with poor venous access or intolerant to venipuncture 25 Unwilling or unable to comply with scheduled visits, treatment plan and other study procedu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters 0.00 (pre-dose) and at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00, 24.00, 48.00 and 72.00 hours post-dose. Phoenix WinNonlin software, Version 8.3 or above. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax 0.00 (pre-dose) and at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00, 24.00, 48.00 and 72.00 hours post-dose. Phoenix WinNonlin software, Version 8.3 or above.,Tmax 0.00 (pre-dose) and at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00, 24.00, 48.00 and 72.00 hours post-dose. Phoenix WinNonlin software, Version 8.3 or above.,AUC 0.00 (pre-dose) and at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00, 24.00, 48.00 and 72.00 hours post-dose. Phoenix WinNonlin software, Version 8.3 or above. | — |
Countries
Thailand
Contacts
Public ContactPorranee Puranajoti
International Bio Service Co., Ltd.
Outcome results
None listed