Bioequivalence of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Volunteers

NCT02221414 | Completed Phase 1

• 1 other identifier: 1288.2
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to demonstrate bioequivalence of a 2.5 mg linagliptin / 500 mg metformin fixed dose combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 500 mg administered together

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• AUC0-72 (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 h)

  up to 72 hours

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 72 hours

• AUC0-∞ (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)

  up to 72 hours

Secondary Outcomes (15)

• AUC0-∞ (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity)

  up to 72 hours

• AUC0-tz (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)

  up to 72 hours

• %AUCtz-∞ (percentage of AUCtz-∞ obtained by extrapolation)

  up to 72 hours

• AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)

  up to 72 hours

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  up to 72 hours

Study Arms (2)

Treatment A (FDC)

EXPERIMENTAL

Drug: Linagliptin/Metformin FDC

Treatment B (single agents)

ACTIVE COMPARATOR

Drug: Linagliptin; Drug: Metformin

Interventions

Linagliptin/Metformin FDC DRUG

Treatment A (FDC)

Linagliptin DRUG

Treatment B (single agents)

Metformin DRUG

Treatment B (single agents)

Eligibility Criteria

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

You may qualify if:

• Healthy men and women 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 (inclusive)
• Body mass index (BMI) 18.5 to 29.9 kg/m2 (inclusive)
• 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 1 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 or 3 pipes daily)
• Alcohol abuse (average consumption of more than 20 g/day in women and 30 g/day in men)
• Drug abuse
• Blood donation (more than 100 mL within 4 weeks before Day 1 of Visit 2)
• Any laboratory value outside the reference range of clinical relevance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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

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: August 19, 2014
• First Posted: August 20, 2014
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Last Updated: August 20, 2014

Record last verified: 2014-08