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Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin

NCT ID: NCT01540487

Last Updated: 2013-08-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-06-30

Brief Summary

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The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of linagliptin and metformin compared to the administration of two single tablets (linagliptin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patients' compliance with antidiabetic treatment., in particular with concern to the frequent polypharmacy in diabetic patients.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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linagliptin/metformin(high dose)

24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of linagliptin /metformin (high dose) and single linagliptin and metformin (high dose) tablets single dose in randomized order

Group Type EXPERIMENTAL

linagliptin/metformin(high dose)

Intervention Type DRUG

patient would take fixed dose combination tablets of linagliptin /metformin (high dose) and single linagliptin and metformin (High dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.

linagliptin/metformin(low dose)

24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of linagliptin /metformin (low dose) and single linagliptin and metformin (low dose) tablets single dose in randomized order

Group Type EXPERIMENTAL

Linagliptin/metformin(low dose)

Intervention Type DRUG

patient would take fixed dose combination tablets of linagliptin /metformin (low dose) and single linagliptin and metformin (Low dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.

Interventions

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linagliptin/metformin(high dose)

patient would take fixed dose combination tablets of linagliptin /metformin (high dose) and single linagliptin and metformin (High dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.

Intervention Type DRUG

Linagliptin/metformin(low dose)

patient would take fixed dose combination tablets of linagliptin /metformin (low dose) and single linagliptin and metformin (Low dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male and female subjects

Exclusion Criteria

1\. Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1288.5.86001 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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1288.5

Identifier Type: -

Identifier Source: org_study_id