Relative Bioavailability of Two Different Batches of a 2.5 mg Linagliptin / 1000 mg Metformin Fixed Dose Combination Tablet (FDC) in Healthy Male and Female Volunteers (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial)

简要总结

主要结局

次要结局

• Metformin: Percentage of AUCtz-∞ Obtained by Extrapolation(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Linagliptin: AUC0-infinity(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Linagliptin: Percentage of AUCtz-∞ Obtained by Extrapolation(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Linagliptin: Time to Maximum Measured Concentration of the Analyte in Plasma (Tmax)(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Linagliptin: λz (Terminal Elimination Rate Constant in Plasma)(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• t1/2 (Terminal Half-life of the Analyte in Plasma)(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Linagliptin: MRTpo (Mean Residence Time of the Analyte in the Body After Peroral Administration)(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Linagliptin: Apparent Clearance of the Analyte in Plasma After Extravascular Administration (CL/F)(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Linagliptin: Apparent Volume of Distribution During the Terminal Phase Following an Extravascular Dose (Vz/F)(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Metformin: AUC0-infinity(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Metformin: Tmax(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Metformin: λz (Terminal Elimination Rate Constant in Plasma)(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Metformin: t1/2 (Terminal Half-life of the Analyte in Plasma)(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Metformin: MRTpo (Mean Residence Time of the Analyte in the Body After Peroral Administration)(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Metformin: CL/F(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Metformin: Vz/F(Day 1 to 35 for period 1, and Day 36 to 70 for period 2)
• Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities(Day 1 to 4 for period 1, and day 36 to 39 for period 2)
• Participants With Treatment Emergent Adverse Events(Day 1 to 4 for period 1, and day 36 to 39 for period 2)
• Participants Who Discontinued the Trial Because of an Adverse Event(Day 1 to 4 for period 1, and day 36 to 39 for period 2)
• Assessment of Tolerability by the Investigator(Day 1 to 4 for period 1, and day 36 to 39 for period 2)