NCT01845077

Brief Summary

The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin \& metformin and the single tablets of linagliptin and metformin when administered singularly.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 19, 2014

Completed
Last Updated

August 19, 2014

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

April 30, 2013

Results QC Date

July 29, 2014

Last Update Submit

July 29, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • AUC0-72 of Linagliptin

    Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.

    1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period

  • Cmax of Linagliptin

    Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.

    1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period

  • AUC0-tz of Metformin

    Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.

    1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period

  • Cmax of Metformin

    Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.

    1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period

Secondary Outcomes (2)

  • AUC0-infinity of Linagliptin

    1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period

  • AUC0-infinity of Metformin

    1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period

Study Arms (6)

5 mg Linagliptin/1000 mg Metformin, fed

ACTIVE COMPARATOR

3 single tablets under fed conditions

Drug: 2x500 mg Metformin (Glumetza)Drug: 5 mg Linagliptin (Tradjenta)

5 mg Linagliptin/1500 mg Metformin FDC

EXPERIMENTAL

2 FDC tablets under fasted conditions

Drug: 2 x 2.5 mg Linagliptin/750 mg Metformin FDC

5 mg Linagliptin/1500 mg Metformin

ACTIVE COMPARATOR

4 single tablets under fasted conditions

Drug: 3x500 mg Metformin (Glumetza)Drug: 5 mg Linagliptin (Tradjenta)

5 mg Linagliptin/1000 mg Metformin FDC

EXPERIMENTAL

1 fixed dose combination(FDC) tablet under fasted conditions

Drug: 5 mg Linagliptin/1000mg Metformin FDC

5 mg Linagliptin/1000 mg Metformin

ACTIVE COMPARATOR

3 single tablets under fasted conditions

Drug: 5 mg Linagliptin (Tradjenta)Drug: 2 x 500 mg Metformin (Glumetza)

5mg Linagliptin/1000mg Metformin, FDCfed

EXPERIMENTAL

1 FDC tablet under fed conditions

Drug: 5 mg Linagliptin/1000 mg Metformin FDC

Interventions

2x500 mg Metformin (Glumetza)DRUG

2 tablets

5 mg Linagliptin/1000 mg Metformin, fed
5 mg Linagliptin/1000 mg Metformin FDCDRUG

FDC tablet

5mg Linagliptin/1000mg Metformin, FDCfed
5 mg Linagliptin (Tradjenta)DRUG

1 tablet

5 mg Linagliptin/1000 mg Metformin, fed
3x500 mg Metformin (Glumetza)DRUG

3 tablets

5 mg Linagliptin/1500 mg Metformin
2 x 500 mg Metformin (Glumetza)DRUG

2 tablets

5 mg Linagliptin/1000 mg Metformin
5 mg Linagliptin/1000mg Metformin FDCDRUG

FDC Tablet

5 mg Linagliptin/1000 mg Metformin FDC
2 x 2.5 mg Linagliptin/750 mg Metformin FDCDRUG

2 FDC tablets

5 mg Linagliptin/1500 mg Metformin FDC

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males or females
  • Age 18 -50 years (incl)
  • Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
  • Subjects must be able to understand and comply with study requirements

You may not qualify if:

  • Any deviation from healthy condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1288.8.1 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

MeSH Terms

Interventions

MetforminLinagliptin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
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

April 30, 2013

First Posted

May 3, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 19, 2014

Results First Posted

August 19, 2014

Record last verified: 2014-07

Locations

US(1)