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To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects.
To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and in combination, in healthy Chinese subjects.
To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amlodipine/telmisartan/combination | Experimental | all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amlodipine/telmisartan/combination | Drug | patient would take amlodipine(5mg)/telmisartan(80mg)/combination(T80+A5mg) single dose in random order, and each dosage will be separated in 21 days interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC_0-tz) | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs | |
| Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs | |
| The Maximum Observed Plasma Concentration (Cmax) of Telmisartan | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs | |
| AUC_0-tz of Amlodipine | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs | |
| AUC_0-∞ of Amlodipine | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs | |
| Cmax of Amlodipine | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Attain Cmax (Tmax) of Telmisartan | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs | |
| Terminal Rate Constant in Plasma (λz) of Telmisartan | reflect the speed of drug elimination in vivo |
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Inclusion criteria
Exclusion criteria
26. No adequate contraception during the study and until 1 month of study completion 27. Lactation period
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1235.30.86001 Boehringer Ingelheim Investigational Site | Shanghai | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Area Under the Concentration-time Curve of Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC_0-tz) | All patients with values for AUC_0-tz of Telmisartan | Posted | Geometric Mean | Geometric Coefficient of Variation | ng·h/mL | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
4 weeks
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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 | Telmisartan 80mg, Amlodipine 5mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals | Boehringer Ingelheim Pharmaceuticals | 800-542-6257 | Option 4 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| C548840 | telmisartan amlodipine combination |
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| 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
| Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po) | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
| Elimination Half-life (t_½) of Telmisartan | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
| Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F) | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
| Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
| Tmax of Amlodipine | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
| λz of Amlodipine | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
| MRT_po of Amlodipine | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
| t_½ of Amlodipine | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
| CL/F of Amlodipine | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
| V_z/F of Amlodipine | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
| Number of Participants With at Least One Treatment Emergent Adverse Event | 4 weeks |
| Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities | 4 weeks |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan | All patients with values for AUC_0-∞ of Telmisartan | Posted | Geometric Mean | Geometric Coefficient of Variation | ng·h/mL | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
|
| Primary | The Maximum Observed Plasma Concentration (Cmax) of Telmisartan | All patients with values for Cmax of Telmisartan | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
|
| Primary | AUC_0-tz of Amlodipine | All patients with values for AUC_0-tz of Amlodipine | Posted | Geometric Mean | Geometric Coefficient of Variation | ng·h/mL | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
|
| Primary | AUC_0-∞ of Amlodipine | All patients with values for AUC_0-∞ of Amlodipine | Posted | Geometric Mean | Geometric Coefficient of Variation | ng·h/mL | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
|
| Primary | Cmax of Amlodipine | All patients with values for Cmax of Amlodipine | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs |
|
|
|
|
| Secondary | Time to Attain Cmax (Tmax) of Telmisartan | All patients with values for tmax of Telmisartan | Posted | Mean | Standard Deviation | h | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | Terminal Rate Constant in Plasma (λz) of Telmisartan | reflect the speed of drug elimination in vivo | All patients with values for λz of Telmisartan | Posted | Mean | Standard Deviation | 1/h | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po) | All patients with values for MRT_po of Telmisartan | Posted | Mean | Standard Deviation | h | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | Elimination Half-life (t_½) of Telmisartan | All patients with values for t_½ of Telmisartan | Posted | Mean | Standard Deviation | h | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F) | All patients with values for CL/F of Telmisartan | Posted | Mean | Standard Deviation | L/h | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan | All patients with values for V_z/F of Telmisartan | Posted | Mean | Standard Deviation | L | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | Tmax of Amlodipine | All patients with values for tmax of Amlodipine | Posted | Mean | Standard Deviation | h | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | λz of Amlodipine | All patients with values for λz of Amlodipine | Posted | Mean | Standard Deviation | 1/h | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | MRT_po of Amlodipine | All patients with values for MRT_po of Amlodipine | Posted | Mean | Standard Deviation | h | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | t_½ of Amlodipine | All patients with values for t_½ of Amlodipine | Posted | Mean | Standard Deviation | h | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | CL/F of Amlodipine | All patients with values for CL/F of Amlodipine | Posted | Mean | Standard Deviation | L/h | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | V_z/F of Amlodipine | All patients with values for V_z/F of Amlodipine | Posted | Mean | Standard Deviation | L | 3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs |
|
|
|
| Secondary | Number of Participants With at Least One Treatment Emergent Adverse Event | Treated set | Posted | Number | Participants | 4 weeks |
|
|
|
| Secondary | Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities | Treated set | Posted | Number | Participants | 4 weeks |
|
|
|
| 0 |
| 27 |
| 2 |
| 27 |
| EG001 | Telmisartan 80mg | 0 | 27 | 1 | 27 |
| EG002 | Amlodipine 5mg | 0 | 26 | 3 | 26 |
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
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| Physical finding abnormalities |
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| Laboratory finding abnormalities |
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