Relative Bioavailability of Two Different Batches of a Linagliptin / Metformin Combination Tablet in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Linagliptin/Metformin (standard batch); Drug: Linagliptin/Metformin (side batch)

• Registration Number: NCT01216397
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the current study is to investigate the relative bioavailability of two different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet (FDC).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Primary Completion: 2010-12
• Results First Submitted: 2012-02-03
• Results First Submitted QC: 2012-03-28
• Results First Posted: 2012-04-25
• Status Verified: 2014-02
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Linagliptin/Metformin (standard batch)	Linagliptin/Metformin (standard batch)	Fixed dose combination tablet
Linagliptin/Metformin (side batch)	Linagliptin/Metformin (side batch)	Fixed dose combination tablet

Primary Outcome Measures

Name	Time	Method
Linagliptin: Maximum Measured Concentration (Cmax)	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric mean of Cmax of Linagliptin
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72)	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric mean of AUC0-72 of Linagliptin
Metformin: Cmax	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric Mean of Cmax of Metformin
Metformin: AUC0-tz	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric Mean of AUC0-tz of Metformin

Secondary Outcome Measures

Name	Time	Method
Linagliptin: AUC0-infinity	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric mean of AUC0-infinity of Linagliptin
Linagliptin: Percentage of AUCtz-∞ Obtained by Extrapolation	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric Mean of percentage of AUCtz-∞ of linagliptin, where percentage is the unit of measurement.
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	Median of the t_max of linagliptin
Linagliptin: λz (Terminal Elimination Rate Constant in Plasma)	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric mean of the λ_z of linagliptin
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	Geometric mean of the t1/2 of linagliptin
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	Geometric mean of the MRTpo of linagliptin
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	Geometric mean of the CL/F of linagliptin
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	Geometric mean of the Vz/F of linagliptin
Metformin: AUC0-infinity	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric Mean of AUC0-infinity of Metformin
Metformin: Percentage of AUCtz-∞ Obtained by Extrapolation	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric Mean of the percentage of AUCtz-infinity of Metformin, where percentage is the unit of measurement.
Metformin: Tmax	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Median of tmax of metformin
Metformin: λz (Terminal Elimination Rate Constant in Plasma)	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric mean of λz of metformin
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	Geometric mean of t1/2 of metformin
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	Geometric mean of MRTpo of metformin
Metformin: CL/F	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric mean of CL/F of metformin
Metformin: Vz/F	Day 1 to 35 for period 1, and Day 36 to 70 for period 2	Geometric mean of Vz/F of metformin
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	12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities
Participants With Treatment Emergent Adverse Events	Day 1 to 4 for period 1, and day 36 to 39 for period 2	Number of patients with treatment emergent AEs
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	Number of participants who discontinued the trial because of an adverse event
Assessment of Tolerability by the Investigator	Day 1 to 4 for period 1, and day 36 to 39 for period 2	Qualitative variable assessing the tolerability by the investigator

Trial Locations

Locations (1)

1288.6.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany