Trial Outcomes & Findings for Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use (NCT NCT02121535)
NCT ID: NCT02121535
Last Updated: 2017-04-12
Results Overview
Area under the concentration-time curve of the telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration
Results posted on
2017-04-12
Participant Flow
The trial was performed as an open-label, randomised, single-dose, two-sequence, four period replicated crossover design. A total of 72 healthy male subjects were randomised to 2 groups (Treatment sequences 1 or 2).
Participant milestones
| Measure |
Sequence TRRT
Oral administration of study drugs in the following order: T (period 1) - R(period 2) - R (period 3) - T (period 4).
T: telmisartan 80mg+amlodipine 5mg+ hydrochlorothiazide (HCTZ) 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg fixed dose combination (FDC) + HCTZ 12.5mg tablet , once daily.
The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period.
|
Sequence RTTR
Oral administration of study drugs in the following order: R (period 1) - T (period 2) - T (period 3) - R (period 4).
T: telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily. The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period.
|
|---|---|---|
|
Period 1 (8 Trial Days)
STARTED
|
36
|
36
|
|
Period 1 (8 Trial Days)
COMPLETED
|
36
|
35
|
|
Period 1 (8 Trial Days)
NOT COMPLETED
|
0
|
1
|
|
Period 2 (8 Trial Days)
STARTED
|
36
|
35
|
|
Period 2 (8 Trial Days)
COMPLETED
|
36
|
35
|
|
Period 2 (8 Trial Days)
NOT COMPLETED
|
0
|
0
|
|
Period 3 (8 Trial Days)
STARTED
|
36
|
35
|
|
Period 3 (8 Trial Days)
COMPLETED
|
35
|
35
|
|
Period 3 (8 Trial Days)
NOT COMPLETED
|
1
|
0
|
|
Period 4 (8 Trial Days)
STARTED
|
35
|
35
|
|
Period 4 (8 Trial Days)
COMPLETED
|
35
|
35
|
|
Period 4 (8 Trial Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence TRRT
Oral administration of study drugs in the following order: T (period 1) - R(period 2) - R (period 3) - T (period 4).
T: telmisartan 80mg+amlodipine 5mg+ hydrochlorothiazide (HCTZ) 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg fixed dose combination (FDC) + HCTZ 12.5mg tablet , once daily.
The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period.
|
Sequence RTTR
Oral administration of study drugs in the following order: R (period 1) - T (period 2) - T (period 3) - R (period 4).
T: telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily. The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period.
|
|---|---|---|
|
Period 1 (8 Trial Days)
Withdrawal by Subject
|
0
|
1
|
|
Period 3 (8 Trial Days)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Bioequivalence Study of Telmisartan Between T80/A5/H12.5 mg FDC Tablet and T80/A5 mg Tab and H12.5 mg Tab Concomitant Use
Baseline characteristics by cohort
| Measure |
Sequence TRRT
n=36 Participants
Oral administration of study drugs in the following order: T (period 1) - R(period 2) - R (period 3) - T (period 4).
T: telmisartan 80mg+amlodipine 5mg+ hydrochlorothiazide (HCTZ) 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg fixed dose combination (FDC) + HCTZ 12.5mg tablet , once daily.
The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period.
|
Sequence RTTR
n=36 Participants
Oral administration of study drugs in the following order: R (period 1) - T (period 2) - T (period 3) - R (period 4). T: telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily. The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.3 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
26.7 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administrationPopulation: Pharmacokinetic set (PKS): included all subjects in the TS who had evaluable pharmacokinetic (PK) variables for both test drug and reference drugs. Subjects who had an important protocol violation (PV) for relevant PK evaluation were excluded from the PKS.
Area under the concentration-time curve of the telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
Outcome measures
| Measure |
Test Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
|
Reference Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
|
|---|---|---|
|
Area Under the Concentration-time Curve of the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)
|
2850 ng*h/mL
Geometric Coefficient of Variation 52.0
|
2790 ng*h/mL
Geometric Coefficient of Variation 54.9
|
PRIMARY outcome
Timeframe: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administrationPopulation: PKS
Cmax (maximum measured concentration of the analyte in plasma)
Outcome measures
| Measure |
Test Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
|
Reference Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
|
|---|---|---|
|
Cmax for Telmisartan
|
718 ng/mL
Geometric Coefficient of Variation 56.4
|
694 ng/mL
Geometric Coefficient of Variation 55.2
|
PRIMARY outcome
Timeframe: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administrationPopulation: PKS
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Outcome measures
| Measure |
Test Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
|
Reference Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
|
|---|---|---|
|
AUC0-tz for Amlodipine
|
171 ng*h/mL
Geometric Coefficient of Variation 24.3
|
172 ng*h/mL
Geometric Coefficient of Variation 25.0
|
PRIMARY outcome
Timeframe: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administrationPopulation: PKS
Cmax (maximum measured concentration of the analyte in plasma)
Outcome measures
| Measure |
Test Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
|
Reference Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
|
|---|---|---|
|
Cmax for Amlodipine
|
3.69 ng/mL
Geometric Coefficient of Variation 22.0
|
3.68 ng/mL
Geometric Coefficient of Variation 20.7
|
PRIMARY outcome
Timeframe: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administrationPopulation: PKS
Cmax (maximum measured concentration of the analyte in plasma)
Outcome measures
| Measure |
Test Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
|
Reference Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
|
|---|---|---|
|
Cmax for Hydrochlorothiazide
|
104 ng/mL
Geometric Coefficient of Variation 23.0
|
94.7 ng/mL
Geometric Coefficient of Variation 23.4
|
PRIMARY outcome
Timeframe: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administrationPopulation: PKS
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Outcome measures
| Measure |
Test Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
|
Reference Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
|
|---|---|---|
|
AUC0-tz for Hydrochlorothiazide
|
638 ng*h/mL
Geometric Coefficient of Variation 19.3
|
611 ng*h/mL
Geometric Coefficient of Variation 19.6
|
SECONDARY outcome
Timeframe: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administrationPopulation: PKS
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Outcome measures
| Measure |
Test Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
|
Reference Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
|
|---|---|---|
|
AUC0-∞ for Telmisartan
|
3090 ng*h/mL
Geometric Coefficient of Variation 54.5
|
3120 ng*h/mL
Geometric Coefficient of Variation 58.8
|
SECONDARY outcome
Timeframe: 3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administrationPopulation: PKS
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Outcome measures
| Measure |
Test Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
|
Reference Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
|
|---|---|---|
|
AUC0-∞ for Amlodipine
|
184 ng*h/mL
Geometric Coefficient of Variation 25.2
|
185 ng*h/mL
Geometric Coefficient of Variation 26.0
|
SECONDARY outcome
Timeframe: 3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administrationPopulation: PKS
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Outcome measures
| Measure |
Test Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
|
Reference Treatment
n=71 Participants
Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
|
|---|---|---|
|
AUC0-∞ for Hydrochlorothiazide
|
661 ng*h/mL
Geometric Coefficient of Variation 18.7
|
634 ng*h/mL
Geometric Coefficient of Variation 18.9
|
Adverse Events
Test Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Total (All Patients)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER