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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017070-21 | EudraCT Number |
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The purpose of this study is to describe the pharmacokinetics of a new oral liquid moxifloxacin formulation and the influence of concommitant food intake on the pharmacokinetics in healthy adults compared to the marketed oral tablet. Pharmacokinetics is to see how the body absorbs, distributes and gets rid of the study drug. The absorption of the drug administered in a different dosage form may be altered due to the influence of different excipients used. The safety of moxifloxacin when administered as an oral liquid formulation will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
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| Arm 2 | Experimental |
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| Arm 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Drug | Single oral dose of moxifloxacin (Avelox, BAY12-8039) IR (immediate release) tablet 400 mg under fasting conditions |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Moxifloxacin after a Single Dose | AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC is defined as area under concentration versus time curve from time 0 (pre-dose) to extrapolated infinite time. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose |
| Maximum Observed Drug Concentration (Cmax) of Moxifloxacin after a Single Dose | Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose |
| Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose(AUC/D) of Moxifloxacin after a Single Dose | Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose |
| Maximum Observed Drug Concentration Adjusted by Dose (Cmax/D) of Moxifloxacin after a Single Dose | Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUC,norm) of Moxifloxacin after a Single Dose | AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUCnorm is defined as AUC divided by dose per kg body weight. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuppertal | North Rhine-Westphalia | 42096 | Germany |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| Moxifloxacin (BAY12-8039) | Drug | Single oral dose of moxifloxacin (BAY12-8039) oral suspension 400 mg under fasting conditions |
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| Moxifloxacin (BAY12-8039) | Drug | Single oral dose of moxifloxacin (BAY12-8039) oral suspension 400 mg under fed conditions |
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| 0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose |
| Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] of Moxifloxacin after a Single Dose | AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC(0-tlast) is defined as AUC from time zero to the last data point above the lower limit of quantification. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose |
| Maximum Observed Plasma Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) of Moxifloxacin after a Single Dose | Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Cmax,norm is defined as Cmax divided by dose per kg body weight. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose |
| Mean Residence Time (MRT) of Moxifloxacin after a Single Dose | MRT is an average duration of the drug in the body, and is expressed in hours. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose |
| Time to Reach Maximum Drug Concentration in Plasma (tmax) of Moxifloxacin after a Single Dose | tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. | 0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose |
| Terminal Half Life Associated With the Terminal Slope (t1/2) of Moxifloxacin after a Single Dose | Half life associated with terminal slope refers to the elimination of the drug. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. It is expressed in hours and derived from the terminal slope of the concentration versus time curve. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose |
| Apparent Oral Clearance (CL/F) of Moxifloxacin after a Single Dose | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. | 0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose |
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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