Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Linagliptin/Pioglitazone; Drug: Linagliptin + Pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01276327

1264.14

2010-022649-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female subjects

Exclusion criteria

Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

1 Linagliptin/Pioglitazone (Test)

Experimental group

Description:

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

Treatment:

Drug: Linagliptin/Pioglitazone

Drug: Linagliptin/Pioglitazone

2 Linagliptin + Pioglitazone (Ref)

Experimental group

Description:

Tablets, oral administration with 240 mL water for each treatment

Treatment:

Drug: Linagliptin + Pioglitazone

Drug: Linagliptin + Pioglitazone

3 Linagliptin/Pioglitazone (Test)

Experimental group

Description:

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

Treatment:

Drug: Linagliptin/Pioglitazone

Drug: Linagliptin/Pioglitazone

4 Linagliptin + Pioglitazone (Ref)

Experimental group

Description:

Tablets, oral administration with 240 mL water for each treatment

Treatment:

Drug: Linagliptin + Pioglitazone

Drug: Linagliptin + Pioglitazone