Relative Bioavailability of Two Different Batches of a Linagliptin / Metformin Combination Tablet in Healthy Volunteers

NCT01216397 | Completed Phase 1 Results

• 2 other identifiers: 1288.62010-019291-75
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the current study is to investigate the relative bioavailability of two different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet (FDC).

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Linagliptin: Maximum Measured Concentration (Cmax)

  Geometric mean of Cmax of Linagliptin

  Day 1 to 35 for period 1, and Day 36 to 70 for period 2

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

  Geometric mean of AUC0-72 of Linagliptin

  Day 1 to 35 for period 1, and Day 36 to 70 for period 2

• Metformin: Cmax

  Geometric Mean of Cmax of Metformin

  Day 1 to 35 for period 1, and Day 36 to 70 for period 2

• Metformin: AUC0-tz

  Geometric Mean of AUC0-tz of Metformin

  Day 1 to 35 for period 1, and Day 36 to 70 for period 2

Secondary Outcomes (20)

• Linagliptin: AUC0-infinity

  Day 1 to 35 for period 1, and Day 36 to 70 for period 2

• Linagliptin: Percentage of AUCtz-∞ Obtained by Extrapolation

  Day 1 to 35 for period 1, and Day 36 to 70 for period 2

• Linagliptin: Time to Maximum Measured Concentration of the Analyte in Plasma (Tmax)

  Day 1 to 35 for period 1, and Day 36 to 70 for period 2

• Linagliptin: λz (Terminal Elimination Rate Constant in Plasma)

  Day 1 to 35 for period 1, and Day 36 to 70 for period 2

• t1/2 (Terminal Half-life of the Analyte in Plasma)

  Day 1 to 35 for period 1, and Day 36 to 70 for period 2

Study Arms (2)

Linagliptin/Metformin (standard batch)

EXPERIMENTAL

Fixed dose combination tablet

Drug: Linagliptin/Metformin (standard batch)

Linagliptin/Metformin (side batch)

EXPERIMENTAL

Fixed dose combination tablet

Drug: Linagliptin/Metformin (side batch)

Interventions

Linagliptin/Metformin (standard batch) DRUG

Fixed dose combination tablet

Linagliptin/Metformin (standard batch)

Linagliptin/Metformin (side batch) DRUG

Fixed dose combination tablet

Linagliptin/Metformin (side batch)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females according to the following criteria: Based upon a complete medical history, including physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
• Age 21 to 50 years (incl.)
• Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration
• Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
• Smoker (more than 10 cigarettes or 3 cigars 3 pipes daily)
• Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to day 1 of visit 2)
• Any laboratory value outside the reference range that is of clinical relevance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1288.6.1 Boehringer Ingelheim Investigational Site

Ingelheim, 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 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: October 4, 2010
• First Posted: October 7, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Last Updated: June 27, 2014
• Results First Posted: April 25, 2012

Record last verified: 2014-02

Locations

DE (1)