Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Metformin (Drug); Linagliptin (Drug); Metformin (Drug); Linagliptin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
Summary
The objective of the current study is to demonstrate bioequivalence of two 2. 5 mg
linagliptin/500 mg metformin fixed dose combination tablets compared to the free combination
of the linagliptin 5 mg and metformin 1000 mg in healthy male and female volunteers.
Clinical Details
Official title: Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto® (Two Fixed Dose Combination Tablets of Linagliptin 2.5 mg and Metformin 500 mg) Compared With the Free Combination of Linagliptin 5 mg and Metformin 1000 mg Tablets Under Fasting Conditions.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Linagliptin: AUC 0-72 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours)Metformin: 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) Linagliptin: Cmax (Maximum Measured Concentration of the Analyte in Plasma) Metformin: Cmax (Maximum Measured Concentration of the Analyte in Plasma)
Secondary outcome: Linagliptin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)Metformin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) Linagliptin: AUC 0-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)
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Signed and dated written informed consent prior to admission to the study in
accordance with Good Clinical Practice and the local legislation
- Healthy males and females 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 (haematology, clinical chemistry and
urinalysis).
- Age 18 to 45 years (incl.)
- Body mass index by Quetelet between 18. 50 to 24. 99 kg/m2 (incl.)
- Female subjects of childbearing potential who agree on using double-barrier
contraception during the study. If a female is postmenopausal (no menses for at least
2 years) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy) she will be exempt from the requirement. In case of using oral
contraceptives, these should be withdrawn at least 2 months before the first drug
dosing.
- Male subjects who agree on using effective contraception during the study (barrier
contraceptive methods)
Exclusion criteria:
- Any finding of the medical examination (including BP, PR and ECG) deviating from
normal and of clinical relevance
- Any laboratory value outside the reference range that is of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
- Positive results of blood tests for infections (HIV, syphilis, hepatitis B or C)
- A positive urine drug screening test at screening and on admission to the trial site
in each treatment period.
- A positive alcohol breath test at screening and on admission to the trial site in
each treatment period.
- Surgery of the gastrointestinal tract (except appendectomy)
Locations and Contacts
1288.21.1 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation
Additional Information
Starting date: November 2013
Last updated: February 24, 2015
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