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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Metformin; Drug: Linagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01947153

1288.21

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 In case of using oral contraceptives, these should be withdrawn at least 2 months before the first drug dosing.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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Fixed dose combination

Experimental group

Description:

Linagliptin/Metformin

Treatment:

Drug: Metformin

Drug: Linagliptin

Drug: Linagliptin

Drug: Metformin

Free combination

Experimental group

Description:

Linagliptin and Metformin

Treatment:

Drug: Metformin

Drug: Linagliptin

Drug: Linagliptin

Drug: Metformin