NCT01276327

Brief Summary

The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

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

Study Start

First participant enrolled

January 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 years until next milestone

Results Posted

Study results publicly available

April 17, 2014

Completed
Last Updated

June 9, 2014

Status Verified

March 1, 2014

Enrollment Period

4 months

First QC Date

January 12, 2011

Results QC Date

March 12, 2014

Last Update Submit

June 3, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • AUC0-72 of Linagliptin

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours

    0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

  • Cmax of Linagliptin

    Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.

    0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

  • AUC0-tz of Pioglitazone

    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

    0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

  • Cmax of Pioglitazone

    Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.

    0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

Secondary Outcomes (5)

  • AUC0-tz for Linagliptin

    0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

  • AUC0-∞ of Linagliptin

    0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

  • AUC0-∞ of Pioglitazone

    0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

  • Tmax for Linagliptin

    0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

  • Tmax for Pioglitazone

    0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)

Study Arms (4)

1 Linagliptin/Pioglitazone (Test)

EXPERIMENTAL

Fixed-Dose-Combination-Tablet, oral administration with 240 mL water

Drug: Linagliptin/Pioglitazone

2 Linagliptin + Pioglitazone (Ref)

EXPERIMENTAL

Tablets, oral administration with 240 mL water for each treatment

Drug: Linagliptin + Pioglitazone

3 Linagliptin/Pioglitazone (Test)

EXPERIMENTAL

Fixed-Dose-Combination-Tablet, oral administration with 240 mL water

Drug: Linagliptin/Pioglitazone

4 Linagliptin + Pioglitazone (Ref)

EXPERIMENTAL

Tablets, oral administration with 240 mL water for each treatment

Drug: Linagliptin + Pioglitazone

Interventions

Linagliptin + PioglitazoneDRUG

Medium doses, oral administration

2 Linagliptin + Pioglitazone (Ref)
Linagliptin/PioglitazoneDRUG

Medium dose oral administration

1 Linagliptin/Pioglitazone (Test)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female subjects

You may not qualify if:

  • Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1264.14.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

LinagliptinPioglitazone

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolinesThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-Ring

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
Yes
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

January 12, 2011

First Posted

January 13, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Last Updated

June 9, 2014

Results First Posted

April 17, 2014

Record last verified: 2014-03

Locations

DE(1)