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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T/A/H | Experimental | Telmisartan/Amlodipine/HCTZ fixed-dose combination |
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| T/A | Active Comparator | Telmisartan/Amlodipine fixed-dose combination |
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| T/H | Active Comparator | Telmisartan/HCTZ fixed-dose combination |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan/Amlodipine | Drug | Telmisartan/Amlodipine fixed-dose combination |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration (Cmax) at Steady State for Telmisartan | Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration |
| Area Under the Plasma Concentration Curve at Steady State for Telmisartan | Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration |
| Maximum Measured Concentration (Cmax) at Steady State for Amlodipine | Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration |
| Area Under the Plasma Concentration Curve at Steady State for Amlodipine | Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration |
| Maximum Measured Concentration (Cmax) at Steady State for HCTZ | Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours | Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state | 0-6 hours (h), 6-12h and 12-24h after drug administration on day 10 |
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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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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1348.5.001 Boehringer Ingelheim Investigational Site | Kanagawa , Yokohama | Japan |
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An open-label, randomised, six-sequence crossover design. Each participant received three treatments each for 10 days. There was no washout period between treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | T80-A5-H12.5 / T80-H12.5 / T80-A5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 (10 Days) |
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| Telmisartan/Amlodipine/HCTZ |
| Drug |
Telmisartan/Amlodipine/HCTZ fixed-dose combination |
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| Telmisartan/HCTZ | Drug | Telmisartan/HCTZ fixed-dose combination |
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| Area Under the Plasma Concentration Curve at Steady State for HCTZ | Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration |
| FG001 | T80-H12.5 / T80-A5 / T80-A5-H12.5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| FG002 | T80-A5 / T80-A5-H12.5 / T80-H12.5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| FG003 | T80-A5 / T80-H12.5 / T80-A5-H12.5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| FG004 | T80-A5-H12.5 / T80-A5 / T80-H12.5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| FG005 | T80-H12.5 / T80-A5-H12.5 / T80-A5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period 2 (10 Days) |
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| Treatment Period 3 (10 Days) |
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Treated set which included all subjects that were dispensed study drug and were documented to have taken at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | T80-A5-H12.5 / T80-H12.5 / T80-A5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| BG001 | T80-H12.5 / T80-A5 / T80-A5-H12.5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| BG002 | T80-A5 / T80-A5-H12.5 / T80-H12.5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| BG003 | T80-A5 / T80-H12.5 / T80-A5-H12.5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| BG004 | T80-A5-H12.5 / T80-A5 / T80-H12.5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| BG005 | T80-H12.5 / T80-A5-H12.5 / T80-A5 | Participants received the three treatments, the treatments were administered orally in the following order:
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| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Measured Concentration (Cmax) at Steady State for Telmisartan | Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau | Pharmacokinetic (PK) set which included all subjects in the treated set who had evaluable PK variable of test (T80/A5/H12.5 mg) and at least one of two references (T80/H12.5 mg and T80/A5 mg) for treatment periods 1, 2, and 3. Subjects who had a protocol deviation relevant to the evaluation of relative bioavailability were excluded. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration |
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| Primary | Area Under the Plasma Concentration Curve at Steady State for Telmisartan | Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration |
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| Secondary | Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours | Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | 0-6 hours (h), 6-12h and 12-24h after drug administration on day 10 |
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| Primary | Maximum Measured Concentration (Cmax) at Steady State for Amlodipine | Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration |
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| Primary | Area Under the Plasma Concentration Curve at Steady State for Amlodipine | Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration |
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| Primary | Maximum Measured Concentration (Cmax) at Steady State for HCTZ | Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration |
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| Primary | Area Under the Plasma Concentration Curve at Steady State for HCTZ | Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration |
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10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T80-A5-H12.5 | Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days. | 0 | 36 | 3 | 36 | ||
| EG001 | T80-H12.5 | Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days | 0 | 36 | 3 | 36 | ||
| EG002 | T80-A5 | Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days | 0 | 34 | 2 | 34 | ||
| EG003 | All Patients | All participants in the study. Participants received three treatments in a randomised order
| 0 | 36 | 5 | 36 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| C548840 | telmisartan amlodipine combination |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| ANOVA | The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. | Adjusted geometric mean ratio (%) | 114.86 | Standard Error of the Mean | 1.097 | 2-Sided | 90 | 98.216 | 134.326 | Ratio calculated as T80-A5-H12.5 divided by T80-A5 | Yes | Non-Inferiority or Equivalence | Non-inferiority limits: 80% - 125% |
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