Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05307614 | Bioequivalence Study of Moksi® 400mg Tablet and Avelox® 400mg Tablet (Moxifloxacin) Under Fasting Condition in Healthy Adult Pakistani Subjects | PHASE1 | COMPLETED | 38 | — | — | Mar 27, 2019 | Apr 27, 2019 | Apr 1, 2022 | 1 | Pakistan |
maximum plasma concentration of Moxifloxacin
Area under plasma concentration time curve from zero to time of the last measurable concentration
area under the plasma concentration-time curve from zero to infinity.
| Arm | Type | Description |
|---|---|---|
| Moksi® 400mg Tablet of Abbott | EXPERIMENTAL | Healthy subjects were orally administered a single dose of Moksi® 400mg Tablet (Moxifloxacin) under fasting condition |
| Avelox® 400mg Tablet of Bayer | ACTIVE_COMPARATOR | Healthy subjects were orally administered a single dose of Avelox® 400mg Tablet (Moxifloxacin) under fasting condition. |
| Name | Type | Description |
|---|---|---|
| Moksi® 400mg Tablet | DRUG | Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast. |
| Drug: Avelox® 400Mg Tablet | DRUG | Single dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast. |
Inclusion Criteria: 1. Healthy male volunteers aged 18 to 55 years inclusive. 2. Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive). 3. Subjects who are healthy as determined by routine physical examination,including vital sign monitoring (ie, blood pressure, heart rate,and temp...