Phase 1
N=72
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02129192 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Maximum Measured Concentration (Cmax) of the Analytes in Plasma — 697; 726; 3.62; 3.57 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Amlodipine 5mg capsule (Drug); T80/H12.5 mg FDC tablet (Drug); T80/A5/H12.5 mg FDC tablet (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Measured Concentration (Cmax) of the Analytes in Plasma |
697; 726; 3.62; 3.57; 98.5; 96.6 | — |
| PRIMARY Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet |
182; 605; 3.54; 3.60; 75.4; 94.6 | 1.0000 |
| PRIMARY Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration |
2580; 2600; 159; 157; 600; 598 | — |
| PRIMARY Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet |
1500; 2350; 156; 157; 515; 575 | 1.0000 |
| SECONDARY Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity |
2750; 2730; 172; 170; 626; 624 | — |
| SECONDARY Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity After Single Administration of T80/A5/H12.5 mg FDC Tablet |
1670; 2530; 168; 169; 542; 603 | 1.0000 |
Summary
To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).
Eligibility Criteria
Inclusion criteria
- Healthy 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)
- 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 (NCT02129192). 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.