Phase 1
Completed N=36
Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.
Healthy
Source: ClinicalTrials.gov NCT01947153 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Linagliptin: AUC 0-72 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours) — 293; 288 nmol*h/L — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Linagliptin: AUC 0-72 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours) |
293; 288 | <0.0001 sig |
| PRIMARY 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) |
13000; 12100 | <0.0001 sig |
| PRIMARY Linagliptin: Cmax (Maximum Measured Concentration of the Analyte in Plasma) |
10.3; 9.57 | 0.0014 sig |
| PRIMARY Metformin: Cmax (Maximum Measured Concentration of the Analyte in Plasma) |
1840; 1700 | <0.0001 sig |
| SECONDARY Linagliptin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) |
467; 479 | <0.0001 sig |
| SECONDARY Metformin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) |
13400; 12500 | <0.0001 sig |
| SECONDARY 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) |
293; 288 | <0.0001 sig |
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)
Data sourced from ClinicalTrials.gov (NCT01947153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.