Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects

NCT02084082 | Completed Phase 1 Results

• 2 other identifiers: 1288.92013-005142-11
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release, both under fed and fasted conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)

  AUC 0-72 (area under concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration

• Maximum Measured Concentration of Linagliptin in Plasma (Cmax)

  Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration

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

  AUC 0-t (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration

• Cmax of Metformin in Plasma

  Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration

Secondary Outcomes (2)

• Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration

• AUC0-inf of Metformin in Plasma

  1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration

Study Arms (4)

FDC first, fasted

EXPERIMENTAL

Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition

Drug: Linagliptin/Metformin ER FDC; Drug: Linagliptin; Drug: Metformin ER

Single tablets first, fasted

EXPERIMENTAL

single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition

Drug: Linagliptin/Metformin ER FDC; Drug: Linagliptin; Drug: Metformin ER

FDC first, fed

EXPERIMENTAL

Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition

Drug: Linagliptin/Metformin ER FDC; Drug: Linagliptin; Drug: Metformin ER

Single tablets first, fed

EXPERIMENTAL

single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition

Drug: Linagliptin/Metformin ER FDC; Drug: Linagliptin; Drug: Metformin ER

Interventions

Linagliptin/Metformin ER FDC DRUG

1x Linagliptin/Metformin FDC tablet

FDC first, fasted; FDC first, fed; Single tablets first, fasted; Single tablets first, fed

Linagliptin DRUG

1x Linagliptin tablet

FDC first, fasted; FDC first, fed; Single tablets first, fasted; Single tablets first, fed

Metformin ER DRUG

2x Metformin ER tablets

FDC first, fasted; FDC first, fed; Single tablets first, fasted; Single tablets first, fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Healthy male or female subjects

You may not qualify if:

• \- Any relevant deviation from healthy condition

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

1288.9.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

Linagliptin; Metformin

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 11, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 4, 2016
• Results First Posted: August 4, 2016

Record last verified: 2015-08

Locations

DE (1)