Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®. | RxWiki

Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Healthy
Intervention	Drug: Metformin Drug: Linagliptin Drug: Metformin Drug: Linagliptin
Phase	Phase 1
Sponsor	Boehringer Ingelheim
Responsible Party	Boehringer Ingelheim
ClinicalTrials.gov Identifier	NCT01947153
First Received	September 18, 2013
Last Updated	February 5, 2014
Last verified	February 2014

Tracking Information[ + expand ][ + ]

First Received Date	September 18, 2013
Last Updated Date	February 5, 2014
Start Date	November 2013
Estimated Primary Completion Date	January 2014
Current Primary Outcome Measures	Linagliptin: AUC 0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours) [Time Frame: 72hours] [Designated as safety issue: No] 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) [Time Frame: up to 4 days] [Designated as safety issue: No] Linagliptin: Cmax (maximum measured concentration of the analyte in plasma) [Time Frame: up to 4 days] [Designated as safety issue: No] Metformin: Cmax (maximum measured concentration of the analyte in plasma) [Time Frame: up to 4 days] [Designated as safety issue: No]
Current Secondary Outcome Measures	Linagliptin and metformin: AUC 0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [Time Frame: up to 4 days] [Designated as safety issue: No] 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) [Time Frame: up to 4 days] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.
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.
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Healthy
Intervention	Drug: Metformin Free combination Drug: Linagliptin Fixed dose combination Drug: Metformin Combination Drug: Linagliptin Free combination
Study Arm (s)	Experimental: Fixed dose combination Linagliptin/Metformin Experimental: Free combination Linagliptin and Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	36
Estimated Completion Date	January 2014
Estimated Primary Completion Date	January 2014
Eligibility 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)
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Russian Federation

Administrative Information[ + expand ][ + ]

NCT Number	NCT01947153
Other Study ID Numbers	1288.21
Has Data Monitoring Committee	Not Provided
Information Provided By	Boehringer Ingelheim
Study Sponsor	Boehringer Ingelheim
Collaborators	Not Provided
Investigators	Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Verification Date	February 2014

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