check_circleStudy Completed
Healthy
Bayer Identifier:
14413
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Bioavailability, food effect and safety, tolerability of a new oral suspension in comparison to the marketed moxifloxacin tablet in healthy adults
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - 55 YearsTrial summary
Enrollment Goal
24Trial Dates
May 2010 - January 2011Phase
Phase 1Could I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bayer HealthCare | Wuppertal, 42096, Germany |
Primary Outcome
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Moxifloxacin after a Single DoseAUC 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.date_rangeTime Frame: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 postdoseenhanced_encryptionnoSafety Issue:
- Maximum Observed Drug Concentration (Cmax) of Moxifloxacin after a Single DoseCmax 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.date_rangeTime Frame: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 postdoseenhanced_encryptionnoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose(AUC/D) of Moxifloxacin after a Single DoseGeometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame: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 postdoseenhanced_encryptionNoSafety Issue:
- Maximum Observed Drug Concentration Adjusted by Dose (Cmax/D) of Moxifloxacin after a Single DoseGeometric mean and percentage geometric coefficient of variation (%CV) were reported.date_rangeTime Frame: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 postdoseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- 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 DoseAUC 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.date_rangeTime Frame: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 postdoseenhanced_encryptionNoSafety Issue:
- Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] of Moxifloxacin after a Single DoseAUC 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.date_rangeTime Frame: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 postdoseenhanced_encryptionNoSafety Issue:
- Maximum Observed Plasma Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) of Moxifloxacin after a Single DoseCmax 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.date_rangeTime Frame: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 postdoseenhanced_encryptionNoSafety Issue:
- Mean Residence Time (MRT) of Moxifloxacin after a Single DoseMRT 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.date_rangeTime Frame: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 postdoseenhanced_encryptionNoSafety Issue:
- Time to Reach Maximum Drug Concentration in Plasma (tmax) of Moxifloxacin after a Single Dosetmax 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.date_rangeTime Frame: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 postdoseenhanced_encryptionNoSafety Issue:
- Terminal Half Life Associated With the Terminal Slope (t1/2) of Moxifloxacin after a Single DoseHalf 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.date_rangeTime Frame: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 postdoseenhanced_encryptionNoSafety Issue:
- Apparent Oral Clearance (CL/F) of Moxifloxacin after a Single DoseClearance 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.date_rangeTime Frame: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 postdoseenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
3Additional Information
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