Relative Bioavailability of Two Fixed Dose Combination Tablets of Linagliptin/Pioglitazone Compared With Single Linagliptin and Pioglitazone Tablets Administered Together to Healthy Male and Female Subjects

NCT02183636 | Completed Phase 1

• 1 other identifier: 1264.1
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

Determination of the relative bioavailability of 2 different formulations of a 5 mg linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination (FDC) tablet, formulation C5 and formulation C8, compared with the mono-components linagliptin and pioglitazone administered together

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

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

  1 hour prior drug administration and up to 120 h after drug administration

• Cmax (maximum measured concentration of linagliptin in plasma)

  1 hour prior drug administration and up to 120 h after drug administration

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

  1 hour prior drug administration and up to 72 h after drug administration

• Cmax (maximum measured concentration of pioglitazone in plasma)

  1 hour prior drug administration and up to 72 h after drug administration

Secondary Outcomes (6)

• 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)

  1 hour prior drug administration and up to 120 h after drug administration

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

  1 hour prior drug administration and up to 120 h after drug administration

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

  1 hour prior drug administration and up to 72 after drug administration

• Changes from baseline in vital signs (blood pressure (BP) and pulse rate (PR))

  21 to 1 day prior start of treatment, at study visits 2 to 4 (prior to treatment administration and 24 h following treatment administration), and 7 days after last treatment administration

• Occurrence of adverse events (AEs)

  until 7 days after last treatment administration

Study Arms (3)

Treatment 1 (T1)

EXPERIMENTAL

Linagliptin/pioglitazone, FDC formulation C5

Drug: Linagliptin/pioglitazone, FDC formulation C5

Treatment 2 (T2)

EXPERIMENTAL

Linagliptin/pioglitazone, FDC formulation C8

Drug: Linagliptin/pioglitazone, FDC formulation C8

Reference (R)

ACTIVE COMPARATOR

Linagliptin tablet and pioglitazone tablet (Actos®)

Drug: Linagliptin tablet; Drug: pioglitazone tablet (Actos®)

Interventions

Linagliptin/pioglitazone, FDC formulation C5 DRUG

film coated tablet (5 mg/45 mg)

Treatment 1 (T1)

Linagliptin/pioglitazone, FDC formulation C8 DRUG

film coated tablet (5 mg/45 mg)

Treatment 2 (T2)

Linagliptin tablet DRUG

5 mg

Reference (R)

pioglitazone tablet (Actos®) DRUG

45 mg

Reference (R)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects according to the following criteria: based upon a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Age ≥18 and ≤55 years
• Body mass index (BMI) ≥18.5 and ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study, in accordance with 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), psychiatric disorders, or neurological disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (\>24 h) within at least 1 month or less than 10 halflives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial or based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 30 g/day for males and 20 g/day for females)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Linagliptin; Pioglitazone

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring

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: July 7, 2014
• First Posted: July 8, 2014
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Last Updated: July 8, 2014

Record last verified: 2014-07