[60290850]
During conduction of a bioequivalence study of fexofenadine/pseudoephedrine 60/120 mg (on (b)(6) 2016), an abon (biopharm) multi-drug 5 panel screen test (coc-thc-amp-mop-tra) for urine sample was used prior to conducting the study to screen for drug abuse in healthy male volunteers recruited and included in the study the result was negative for the 5 drugs (coc-thc-amp-mop-tra) before dosing the volunteers then after dosing the volunteers another random screen test was conducted for a volunteer at the 8 hour interval post dosing and the test showed a positive for (tra) and negative for the rest (coc-thc-amp-mop) although the volunteer is healthy and not abusing (tra) and showed a negative result for the test predosing so an investigation was carried out on another new three healthy male volunteers other than those included in the study where a predose abon (biopharm) multi-drug 5 panel screen test was carried out and showed negative results for the 5 drugs (coc-thc-amp-mop-tra) then a single dose of fexofenadine/pseudoephedrine 60/120 mg was administered by the three volunteers and a urine sample was collected 2 and 4 hours postdose and an abon (biopharm) multi-drug 5 panel screen test was carried out. The results showed positive for (tra) and negative for (coc-thc-amp-mop-tra) although they are not abusing (tra) and showed a negative result for the test predosing so according to this result a cross reaction of pseudoephedrine is suspected which may have shown the false positive results for (tra) post dosing. Dates of use: (b)(6) 2016. Diagnosis or reason for use: bioequivalence study. Is the product over-the-counter: yes. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5