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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

Page last updated: August 23, 2015

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