Phase 1
Completed N=72
Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use
Healthy
Source: ClinicalTrials.gov NCT02121535 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Area Under the Concentration-time Curve of the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) — 2850; 2790 ng*h/mL
Summary
The study will be performed as an open-label, randomised, single-dose, two-sequence, four-period replicated crossover design. A total of 72 Japanese healthy male subjects will be randomised to 2 groups. The subjects are administrated either T80/A5/H12.5 mg FDC tablet once or T80/A5 mg FDC tablet and hydrochlorothiazide (HCTZ) 12.5 mg tablet once in each period. The length of admission will be 7 days in each period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) |
2850; 2790 | — |
| PRIMARY Cmax for Telmisartan |
718; 694 | — |
| PRIMARY AUC0-tz for Amlodipine |
171; 172 | — |
| PRIMARY Cmax for Amlodipine |
3.69; 3.68 | — |
| PRIMARY Cmax for Hydrochlorothiazide |
104; 94.7 | — |
| PRIMARY AUC0-tz for Hydrochlorothiazide |
638; 611 | — |
| SECONDARY AUC0-∞ for Telmisartan |
3090; 3120 | — |
| SECONDARY AUC0-∞ for Amlodipine |
184; 185 | — |
| SECONDARY AUC0-∞ for Hydrochlorothiazide |
661; 634 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects age =20 and =35 years; body weight: =50 kg and =80 kg; body mass index: =18.0 and =25.0 kg/m2
- Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiograms (ECGs), clinical laboratory tests
- Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.
Exclusion criteria
- Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance.
Data sourced from ClinicalTrials.gov (NCT02121535). 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.