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To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T80/A5/H12.5 mg FDC | Experimental | Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet |
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| T80/H12.5 FDC + A5 mono | Active Comparator | Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine 5mg capsule | Drug | Amlodipine 5mg capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration (Cmax) of the Analytes in Plasma | Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma | 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
| Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet | Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet | 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
| 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 | Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration | 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
| 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 | Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity | Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity | 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
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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 |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Tokyo, Hachioji | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence TRRTT | Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5: T (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T. Treatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 Including Washout Period |
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| T80/H12.5 mg FDC tablet |
| Drug |
Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet |
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| T80/A5/H12.5 mg FDC tablet | Drug | Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet |
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| 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
| 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 | Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity after single administration of T80/A5/H12.5 mg FDC tablet | 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
| FG001 | Sequence RTTR | Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4: R - T - T - R. The treatments were administered following an overnight fast of at least 10 hours. |
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| NOT COMPLETED |
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| Period 2 Including Washout Period |
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| Period 3 Including Washout Period |
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| Period 4 Including Washout Period |
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| Period 5 |
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Treated Set (TS): This subject set included all subjects who were dispensed the study drug and were documented to have taken at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence TRRTT | Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5: T (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T. Treatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration |
| BG001 | Sequence RTTR | Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4: R - T - T - R. The treatments were administered following an overnight fast of at least 10 hours. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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) of the Analytes in Plasma | Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma | Pharmacokinetic set (PKS) which included all healthy subjects in the TS who had evaluable PK variables for both treatments (i.e. had data of at least one analyte for both test and reference products) in periods 1, 2, 3 and 4. Subjects who had an important protocol violation relevant to PK evaluation were to be excluded from the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
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| Primary | Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet | Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet | Food effect analysis set (FEAS) which included healthy subjects of treatment sequence TRRTT in the TS who were judged appropriate to continue to period 5 by the investigator, had evaluable PK variables for both feeding conditions and did not have an important protocol violation relevant to relative bioavailability evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
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| 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 | Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
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| 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 | Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ 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 | FEAS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
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| Secondary | Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity | Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
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| 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 | Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity after single administration of T80/A5/H12.5 mg FDC tablet | FEAS | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only |
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From first drug administration until end of washout period (14 days) or 144 hours after last drug administration (6 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 mg FDC | Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet | 0 | 71 | 11 | 71 | ||
| EG001 | T80/H12.5 FDC + A5 Capsule | Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule | 0 | 72 | 6 | 72 | ||
| EG002 | Total. | All participants randomised into the study. | 0 | 72 | 16 | 72 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 17.0 | 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 |
|---|---|
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| HCTZ |
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| Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg | Mixed Models Analysis | Model on logarithmic scale included "subjects within sequence" as random effect and "sequence", "period", and "treatment" as fixed effects. | Adjusted geometric mean ratio (%) | 101.40 | 2-Sided | 90 | 99.70 | 103.13 | Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono. | Non-Inferiority or Equivalence | Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%) |
| Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg | Mixed Models Analysis | Model on logarithmic scale included "subjects within sequence" as random effect and "sequence", "period", and "treatment" as fixed effects. | Adjusted geometric mean ratio (%) | 101.77 | 2-Sided | 90 | 98.46 | 105.19 | Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono. | Non-Inferiority or Equivalence | Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%) |
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