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| Name | Class |
|---|---|
| SAMI Pharmaceuticals (Pvt.) Ltd. | INDUSTRY |
| Center for Bioequivalence Studies and Clinical Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | Subjects will be given one Mofest® 400mg (Moxifloxacin HCl) Tablet (1x400mg) manufactured by SAMI Pharmaceuticals (Pvt.) after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. Blood samples will be taken up to 72.0 hours post-dose. |
|
| Reference Group | Active Comparator | Subjects will be given one Avelox® 400mg (Moxifloxacin HCl) Tablet (1x400mg), manufactured by Bayer HealthCare, after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. Blood samples will be taken up to 72.0 hours post-dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin 400mg | Drug | Moxifloxacin 400mg IR tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximum plasma concentration | maximum drug concentration in plasma after dose | up to 72 hours post dose |
| Time to reach maximum plasma concentration | Time required for the drug to reach maximum plasma concentration | 0 to 72 hours post dose |
| AUC | Area under the time versus plasma drug concentration curve | 0-72 hours |
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Inclusion Criteria:
Exclusion Criteria:
Pakistani Population
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Muhammad R Shah, PhD | CBSCR, ICCBS, University of Karachi, Pakistan | Principal Investigator |
| Dr. Naghma Hashmi (Co-PI), PhD | CBSCR, ICCBS, University of Karachi, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Bioequivalence Studies and clinical research | Karachi | Sindh | 75270 | Pakistan |
Individual participant data (IPD) will only be available to other researchers upon reasonable request to PI keeping the participants' confidentiality intact.
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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A single center, open label, randomized, single-dose, two-period, two-way cross-over study
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |