Bioequivalence Study of Mofest® 400mg (Moxifloxacin) Tablet With Avelox® 400mg (Moxifloxacin) Tab… (NCT04873570) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Mofest® 400mg (Moxifloxacin) Tablet With Avelox® 400mg (Moxifloxacin) Tablet in Healthy Pakistani Subjects
Pakistan38 participantsStarted 2021-05-28
Plain-language summary
Single oral dose, of test and reference Tablet will be administered to healthy volunteers, after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-points. Blood samples will be taken up to 72.0 hours post-dose.
Who can participate
Age range18 Years – 55 Years
SexMALE
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Inclusion Criteria:
* Healthy subjects aged 18 to 55 years inclusive.
* Subjects with a body mass index (BMI) from 18.5 to 30 kg/m2.
* Subject is able to fast for 14 hours and consume standard meals.
* Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate, and temperature), 12-Lead ECG, and safety laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis) or viral serology as determined by the investigator.
* Subjects should have negative urine test for drugs of abuse (morphine \& cannabinoids will be tested) and alcohol breath analysis at screening and prior to each check-in.
* Subjects who are able to, understand and sign the Informed Consent Form for Medical Screening during their screening visit and Participation Informed Consent Form on study check-In day.
* Subject agreed not to consume food or beverages including dairy products, tea, coffee, cola drinks, chocolates containing xanthine derivatives (including caffeine, theobromines, etc.) and/or poppy seeds (Khash khash) within 48 hours prior to drug administration until last blood draw in each study period.
* Subject agreed not to intake prescription drugs (especially amiodarone, carbamazepine, Antacids (aluminum and magnesium hydroxides) NSAIDS, digoxin and Blood thinners such as warfarin, etc.) within 14 days or 5 half-lives (whichever is longer) prior to first dose of study medicine.
* Subject agreed not to intake non…