Trial Outcomes & Findings for Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use (NCT NCT01344629)

NCT ID: NCT01344629

Last Updated: 2014-03-28

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

64 participants

Primary outcome timeframe

Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration

Results posted on

2014-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Sequence A T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet	Treatment Sequence B Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
Crossover Period 1 STARTED	32	32
Crossover Period 1 COMPLETED	32	32
Crossover Period 1 NOT COMPLETED	0	0
Crossover Period 2 STARTED	32	32
Crossover Period 2 COMPLETED	32	31
Crossover Period 2 NOT COMPLETED	0	1
Crossover Period 3 STARTED	32	31
Crossover Period 3 COMPLETED	32	31
Crossover Period 3 NOT COMPLETED	0	0
Crossover Period 4 STARTED	32	31
Crossover Period 4 COMPLETED	32	31
Crossover Period 4 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Sequence A T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet	Treatment Sequence B Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
Crossover Period 2 Withdrawal by Subject	0	1

Baseline Characteristics

Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Sequence A n=32 Participants	Treatment Sequence B n=32 Participants	Total n=64 Participants Total of all reporting groups
Age, Continuous	24.1 Year STANDARD_DEVIATION 3.3 • n=5 Participants	24.5 Year STANDARD_DEVIATION 3.8 • n=7 Participants	24.3 Year STANDARD_DEVIATION 3.5 • 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	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration

Population: One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.

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

Outcome measures

Outcome measures
Measure	T80/A5 mg FDC Tablet n=126 Participants	T80mg Tablet and A5 mg Tablet in Concomitant Use n=126 Participants
AUC0-tz	1970 ng*hour/mL Geometric Coefficient of Variation 67.9	1950 ng*hour/mL Geometric Coefficient of Variation 67.0

PRIMARY outcome

Timeframe: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration

Population: One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.

maximum measured concentration of Telmisartan in plasma

Outcome measures

Outcome measures
Measure	T80/A5 mg FDC Tablet n=126 Participants	T80mg Tablet and A5 mg Tablet in Concomitant Use n=126 Participants
Cmax	471 ng/mL Geometric Coefficient of Variation 88.1	484 ng/mL Geometric Coefficient of Variation 81.8

SECONDARY outcome

Timeframe: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration

Population: One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.

area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity

Outcome measures

Outcome measures
Measure	T80/A5 mg FDC Tablet n=110 Participants	T80mg Tablet and A5 mg Tablet in Concomitant Use n=112 Participants
AUC0-∞	2410 ng*hour/mL Geometric Coefficient of Variation 60.4	2300 ng*hour/mL Geometric Coefficient of Variation 62.4

SECONDARY outcome

Timeframe: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration

Population: One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.

time from dosing to the maximum concentration of Telmisartan in plasma

Outcome measures

Outcome measures
Measure	T80/A5 mg FDC Tablet n=126 Participants	T80mg Tablet and A5 mg Tablet in Concomitant Use n=126 Participants
Tmax	0.750 hour Full Range 0.500 • Interval 0.5 to 4.0	0.750 hour Full Range 0.250 • Interval 0.25 to 4.0

SECONDARY outcome

Timeframe: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration

Population: One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.

terminal rate constant of Telmisartan in plasma

Outcome measures

Outcome measures
Measure	T80/A5 mg FDC Tablet n=110 Participants	T80mg Tablet and A5 mg Tablet in Concomitant Use n=112 Participants
λz	0.0297 /hour Geometric Coefficient of Variation 52.5	0.0326 /hour Geometric Coefficient of Variation 45.1

SECONDARY outcome

Timeframe: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration

Population: One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.

terminal half-life of Telmisartan in plasma

Outcome measures

Outcome measures
Measure	T80/A5 mg FDC Tablet n=110 Participants	T80mg Tablet and A5 mg Tablet in Concomitant Use n=112 Participants
t1/2	23.3 hour Geometric Coefficient of Variation 52.5	21.3 hour Geometric Coefficient of Variation 45.1

SECONDARY outcome

Timeframe: Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration

Population: One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.

mean residence time of Telmisartan in the body after oral administration

Outcome measures

Outcome measures
Measure	T80/A5 mg FDC Tablet n=110 Participants	T80mg Tablet and A5 mg Tablet in Concomitant Use n=112 Participants
MRTpo	21.8 hour Geometric Coefficient of Variation 56.2	19.9 hour Geometric Coefficient of Variation 50.5

Adverse Events

Treatment Sequence A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Sequence B

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

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER