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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Linagliptin; Metformin

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 In case of using oral contraceptives, these should be withdrawn at least 2 months before the first drug dosing.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)