Healthy
Conditions
Brief summary
To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).
Interventions
DRUGAmlodipine 5mg capsule
Amlodipine 5mg capsule
DRUGT80/H12.5 mg FDC tablet
Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet
Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects age \>=20 and \<=35 years; body weight: \>=50 kg and \<=80 kg; body mass index: \>=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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Measured Concentration (Cmax) of the Analytes 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 telmisartan, amlodipine and HCTZ in plasma |
| Maximum Measured Concentration (Cmax) of the Analytes in Plasma 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 | Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet |
| 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 | 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 telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration |
| 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 | 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes 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 | 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 |
| 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 | 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 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 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| 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. | 36 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 Including Washout Period | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Sequence TRRTT | Sequence RTTR | Total |
|---|---|---|---|
| Age, Continuous | 26.6 Years STANDARD_DEVIATION 4.2 | 26.6 Years STANDARD_DEVIATION 3.9 | 26.6 Years STANDARD_DEVIATION 4 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 36 Participants | 36 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 71 | 6 / 72 | 16 / 72 |
| serious Total, serious adverse events | 0 / 71 | 0 / 72 | 0 / 72 |
Outcome results
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
Time frame: 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
Population: PKS
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5/H12.5 mg FDC | 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 | Telmisartan | 2580 ng*h/mL | Geometric Coefficient of Variation 76.8 |
| T80/A5/H12.5 mg FDC | 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 | Amlodipine | 159 ng*h/mL | Geometric Coefficient of Variation 23.4 |
| T80/A5/H12.5 mg FDC | 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 | HCTZ | 600 ng*h/mL | Geometric Coefficient of Variation 21 |
| T80/H12.5 FDC + A5 Capsule | 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 | Telmisartan | 2600 ng*h/mL | Geometric Coefficient of Variation 76.1 |
| T80/H12.5 FDC + A5 Capsule | 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 | Amlodipine | 157 ng*h/mL | Geometric Coefficient of Variation 24 |
| T80/H12.5 FDC + A5 Capsule | 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 | HCTZ | 598 ng*h/mL | Geometric Coefficient of Variation 19.1 |
Comparison: Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg90% CI: [96.14, 102.38]Mixed Models Analysis
Comparison: Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg90% CI: [99.84, 103.04]Mixed Models Analysis
Comparison: Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg90% CI: [98.29, 102.4]Mixed Models Analysis
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
Time frame: 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
Population: FEAS
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5/H12.5 mg FDC | 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 | Telmisartan | 1500 ng*h/mL | Geometric Coefficient of Variation 98.3 |
| T80/A5/H12.5 mg FDC | 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 | Amlodipine | 156 ng*h/mL | Geometric Coefficient of Variation 23.9 |
| T80/A5/H12.5 mg FDC | 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 | HCTZ | 515 ng*h/mL | Geometric Coefficient of Variation 18.9 |
| T80/H12.5 FDC + A5 Capsule | 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 | Telmisartan | 2350 ng*h/mL | Geometric Coefficient of Variation 93.6 |
| T80/H12.5 FDC + A5 Capsule | 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 | Amlodipine | 157 ng*h/mL | Geometric Coefficient of Variation 26.1 |
| T80/H12.5 FDC + A5 Capsule | 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 | HCTZ | 575 ng*h/mL | Geometric Coefficient of Variation 19.2 |
Comparison: Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.p-value: 190% CI: [58.98, 68.71]ANOVA
Comparison: Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.p-value: <0.000190% CI: [97.08, 102.48]ANOVA
Comparison: Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.p-value: 0.000190% CI: [85.8, 93.7]ANOVA
Primary
Maximum Measured Concentration (Cmax) of the Analytes in Plasma
Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5/H12.5 mg FDC | Maximum Measured Concentration (Cmax) of the Analytes in Plasma | Telmisartan | 697 ng/mL | Geometric Coefficient of Variation 75.5 |
| T80/A5/H12.5 mg FDC | Maximum Measured Concentration (Cmax) of the Analytes in Plasma | Amlodipine | 3.62 ng/mL | Geometric Coefficient of Variation 20.2 |
| T80/A5/H12.5 mg FDC | Maximum Measured Concentration (Cmax) of the Analytes in Plasma | HCTZ | 98.5 ng/mL | Geometric Coefficient of Variation 25.1 |
| T80/H12.5 FDC + A5 Capsule | Maximum Measured Concentration (Cmax) of the Analytes in Plasma | Amlodipine | 3.57 ng/mL | Geometric Coefficient of Variation 19.9 |
| T80/H12.5 FDC + A5 Capsule | Maximum Measured Concentration (Cmax) of the Analytes in Plasma | Telmisartan | 726 ng/mL | Geometric Coefficient of Variation 74.9 |
| T80/H12.5 FDC + A5 Capsule | Maximum Measured Concentration (Cmax) of the Analytes in Plasma | HCTZ | 96.6 ng/mL | Geometric Coefficient of Variation 25.8 |
Comparison: Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg90% CI: [88.89, 103.17]Mixed Models Analysis
Comparison: Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg90% CI: [99.7, 103.13]Mixed Models Analysis
Comparison: Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg90% CI: [98.46, 105.19]Mixed Models Analysis
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
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5/H12.5 mg FDC | Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet | Telmisartan | 182 ng/mL | Geometric Coefficient of Variation 75.9 |
| T80/A5/H12.5 mg FDC | Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet | Amlodipine | 3.54 ng/mL | Geometric Coefficient of Variation 20.6 |
| T80/A5/H12.5 mg FDC | Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet | HCTZ | 75.4 ng/mL | Geometric Coefficient of Variation 16.5 |
| T80/H12.5 FDC + A5 Capsule | Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet | Telmisartan | 605 ng/mL | Geometric Coefficient of Variation 84.4 |
| T80/H12.5 FDC + A5 Capsule | Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet | Amlodipine | 3.60 ng/mL | Geometric Coefficient of Variation 22.4 |
| T80/H12.5 FDC + A5 Capsule | Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet | HCTZ | 94.6 ng/mL | Geometric Coefficient of Variation 20.1 |
Comparison: Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.p-value: 190% CI: [24.99, 36.38]ANOVA
Comparison: Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.p-value: <0.000190% CI: [94.63, 101.97]ANOVA
Comparison: Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.p-value: 0.542290% CI: [74.97, 84.71]ANOVA
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
Time frame: 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
Population: PKS
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5/H12.5 mg FDC | Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity | Telmisartan ( N = 142, 142) | 2750 ng*h/mL | Geometric Coefficient of Variation 79.2 |
| T80/A5/H12.5 mg FDC | Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity | Amlodipine ( N = 142, 142) | 172 ng*h/mL | Geometric Coefficient of Variation 25.4 |
| T80/A5/H12.5 mg FDC | Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity | HCTZ ( N = 141, 142) | 626 ng*h/mL | Geometric Coefficient of Variation 20.2 |
| T80/H12.5 FDC + A5 Capsule | Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity | Telmisartan ( N = 142, 142) | 2730 ng*h/mL | Geometric Coefficient of Variation 73.7 |
| T80/H12.5 FDC + A5 Capsule | Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity | Amlodipine ( N = 142, 142) | 170 ng*h/mL | Geometric Coefficient of Variation 26 |
| T80/H12.5 FDC + A5 Capsule | Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity | HCTZ ( N = 141, 142) | 624 ng*h/mL | Geometric Coefficient of Variation 18.2 |
Comparison: Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg90% CI: [96.32, 103.04]Mixed Models Analysis
Comparison: Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg90% CI: [99.59, 102.87]Mixed Models Analysis
Comparison: Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg90% CI: [98.23, 102.1]Mixed Models Analysis
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
Time frame: 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
Population: FEAS
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| T80/A5/H12.5 mg FDC | 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 | Telmisartan ( N = 35, 36 ) | 1670 ng*h/mL | Geometric Coefficient of Variation 108 |
| T80/A5/H12.5 mg FDC | 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 | Amlodipine ( N = 36, 36 ) | 168 ng*h/mL | Geometric Coefficient of Variation 26 |
| T80/A5/H12.5 mg FDC | 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 | HCTZ ( N = 36, 36 ) | 542 ng*h/mL | Geometric Coefficient of Variation 18.3 |
| T80/H12.5 FDC + A5 Capsule | 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 | Telmisartan ( N = 35, 36 ) | 2530 ng*h/mL | Geometric Coefficient of Variation 98.3 |
| T80/H12.5 FDC + A5 Capsule | 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 | Amlodipine ( N = 36, 36 ) | 169 ng*h/mL | Geometric Coefficient of Variation 28.6 |
| T80/H12.5 FDC + A5 Capsule | 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 | HCTZ ( N = 36, 36 ) | 603 ng*h/mL | Geometric Coefficient of Variation 18.3 |
Comparison: Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.p-value: 190% CI: [59.59, 69.59]ANOVA
Comparison: Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.p-value: <0.000190% CI: [96.69, 102.29]ANOVA
Comparison: Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.p-value: <0.000190% CI: [86.02, 93.79]ANOVA