Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.

Phase 1CompletedNCT01947153

Boehringer Ingelheim36 enrolled

Overview

The objective of the current study is to demonstrate bioequivalence of two 2.5 mg linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

MetforminDRUG

Free combination

LinagliptinDRUG

Fixed dose combination

MetforminDRUG

Combination

Linagliptin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation * Healthy males and females according to the following criteria: Based upon a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests (haematology, clinical chemistry and urinalysis). * Age 18 to 45 years (incl.) * Body mass index by Quetelet between 18.50 to 24.99 kg/m2 (incl.) * Female subjects of childbearing potential who agree on using double-barrier contraception during the study. If a female is postmenopausal (no menses for at least 2 years) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) she will be exempt from the requirement. In case of using oral contraceptives, these should be withdrawn at least 2 months before the first drug dosing. * Male subjects who agree on using effective contraception during the study (barrier contraceptive methods) Exclusion criteria: * Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance * Any laboratory value outside the reference range that is of clinical relevance * Any evidence of a clinically relevant concomitant disease * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Positive results of blood tests for infections (HIV, syphilis, hepatitis B or C) * A positive urine drug screening test at screening and on admission to the trial site in each treatment period. * A positive alcohol breath test at screening and on admission to the trial site in each treatment period. * Surgery of the gastrointestinal tract (except appendectomy)

Locations (1)

1288.21.1 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Linagliptin: AUC 0-72 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours)

Linagliptin: AUC 0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours)

Time frame: 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Metformin: AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)

Metformin: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

Time frame: 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Linagliptin: Cmax (Maximum Measured Concentration of the Analyte in Plasma)

Linagliptin: Cmax (maximum measured concentration of the analyte in plasma)

Time frame: 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Metformin: Cmax (Maximum Measured Concentration of the Analyte in Plasma)

Metformin: Cmax (maximum measured concentration of the analyte in plasma)

Time frame: 2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Secondary Outcomes

Linagliptin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)

Linagliptin: AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Data from ClinicalTrials.gov

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