Bioequivalence Study of Telmisartan Between T80/A5/H12.5... | NCT02121535

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T80/A5/H12.5 mg FDC	Experimental	A Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination (FDC) tablet	Drug: T80/A5 mg FDC tablet Drug: H12.5 mg tablet Drug: T80/A5/H12.5 mg FDC tablet
T80/A5 mg FDC+H12.5 mg mono	Active Comparator	A Telmisartan 80 mg/ Amlodipine 5 mg fixed dose combination (FDC) tablet and a Hydrochlorothiazide 12.5 mg tablet	Drug: T80/A5 mg FDC tablet Drug: T80/A5/H12.5 ng FDC tablet Drug: H12.5 mf tablet

Name	Type	Description	Arm Group Labels	Other Names
T80/A5 mg FDC tablet	Drug		T80/A5/H12.5 mg FDC
T80/A5 mg FDC tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	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)	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
Cmax for Telmisartan	Cmax (maximum measured concentration of the analyte in plasma)	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
AUC0-tz for Amlodipine	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)	3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration
Cmax for Amlodipine	Cmax (maximum measured concentration of the analyte in plasma)	3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration
Cmax for Hydrochlorothiazide	Cmax (maximum measured concentration of the analyte in plasma)	3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration
AUC0-tz for Hydrochlorothiazide

Secondary Outcomes

Measure	Description	Time Frame
AUC0-∞ for Telmisartan	AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	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

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00036 BG00136 BG00272

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 the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)

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)

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.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*h/mL

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

ID	Title	Description
OG000	Test Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
OG001	Reference Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.

Units	Counts
Participants	OG00071 OG00171

Title

Denominators

Categories

Title	Measurements
	OG0002850± 52.0 OG0012790± 54.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.					Adjusted Mean Ratio	101.97			2-Sided	90	98.94	105.08			Adjusted Mean Ratio (Test/Reference)		Non-Inferiority or Equivalence	To determine whether the 2-sided 90% confidence interval (CI) for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.

Primary

Cmax for Telmisartan

Cmax (maximum measured concentration of the analyte in plasma)

PKS

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

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

ID	Title	Description
OG000	Test Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
OG001	Reference Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.

Units	Counts
Participants	OG000

Secondary

AUC0-∞ for Telmisartan

AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

PKS

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*h/mL

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

ID	Title	Description
OG000	Test Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
OG001	Reference Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.

Units	Counts
Participants	OG000

Secondary

AUC0-∞ for Amlodipine

AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

PKS

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*h/mL

3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration

ID	Title	Description
OG000	Test Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
OG001	Reference Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.

Units	Counts
Participants	OG000

Primary

AUC0-tz for Amlodipine

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)

PKS

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*h/mL

3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration

ID	Title	Description
OG000	Test Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
OG001	Reference Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.

Units	Counts
Participants	OG000

Primary

Cmax for Amlodipine

Cmax (maximum measured concentration of the analyte in plasma)

PKS

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration

ID	Title	Description
OG000	Test Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
OG001	Reference Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.

Units	Counts
Participants	OG000

Primary

Cmax for Hydrochlorothiazide

Cmax (maximum measured concentration of the analyte in plasma)

PKS

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration

ID	Title	Description
OG000	Test Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
OG001	Reference Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.

Units	Counts
Participants	OG000

Primary

AUC0-tz for Hydrochlorothiazide

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)

PKS

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*h/mL

3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration

ID	Title	Description
OG000	Test Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
OG001	Reference Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.

Units	Counts
Participants	OG000

Secondary

AUC0-∞ for Hydrochlorothiazide

AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

PKS

Posted

Geometric Mean

Geometric Coefficient of Variation

ng*h/mL

3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration

ID	Title	Description
OG000	Test Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
OG001	Reference Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (At Risk)
EG000	Test Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;	71	71
EG001	Reference Treatment	Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.	72	72
EG002	Total (All Patients)	Total of all the participants analyzed	72	72