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
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ClinicalTrials.gov Identifier: NCT02129192 |
Recruitment Status :
Completed
First Posted : May 2, 2014
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Tracking Information | ||||
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First Submitted Date ICMJE | April 30, 2014 | |||
First Posted Date ICMJE | May 2, 2014 | |||
Results First Submitted Date ICMJE | October 6, 2016 | |||
Results First Posted Date ICMJE | April 12, 2017 | |||
Last Update Posted Date | April 12, 2017 | |||
Study Start Date ICMJE | May 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity [ Time Frame: up to 144hours from drug administration ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | 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 | |||
Official Title ICMJE | Bioequivalence of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet Compared to Concomitant Administration of Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Amlodipine 5 mg Capsule in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study), With Influence of Food on the Bioavailability of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet | |||
Brief Summary | To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
72 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | September 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria: - Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance |
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 35 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02129192 | |||
Other Study ID Numbers ICMJE | 1348.4 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Boehringer Ingelheim | |||
Study Sponsor ICMJE | Boehringer Ingelheim | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Boehringer Ingelheim | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |