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

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 In case of using oral contraceptives, these should be withdrawn at least 2 months before the first drug dosing.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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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