Phase 1
Completed N=36
Pharmacokinetics of Different Formulations of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) in Japanese Healthy Male Volunteers
Healthy
Source: ClinicalTrials.gov NCT02183675 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Maximum Measured Concentration (Cmax) at Steady State for Telmisartan — 970; 857; 895 ng/mL
Summary
To assess drug drug interaction through pharmacokinetics investigation at steady state of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) given as three different formulations in healthy Japanese male subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Measured Concentration (Cmax) at Steady State for Telmisartan |
970; 857; 895 | — |
| PRIMARY Area Under the Plasma Concentration Curve at Steady State for Telmisartan |
2510; 2570; 2580 | — |
| PRIMARY Maximum Measured Concentration (Cmax) at Steady State for Amlodipine |
11.8; 11.3 | — |
| PRIMARY Area Under the Plasma Concentration Curve at Steady State for Amlodipine |
230; 223 | — |
| PRIMARY Maximum Measured Concentration (Cmax) at Steady State for HCTZ |
107; 102 | — |
| PRIMARY Area Under the Plasma Concentration Curve at Steady State for HCTZ |
584; 565 | — |
| SECONDARY Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours |
10.4; 9.9 | — |
Eligibility Criteria
Inclusion criteria
- Healthy Japanese male subjects age >=20 and =50 kg and =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 (NCT02183675). 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.