Trial Outcomes & Findings for Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions (NCT NCT01149486)
NCT ID: NCT01149486
Last Updated: 2010-12-08
Results Overview
Bioequivalence based on Losartan Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Blood samples collected over a 48 hour period.
Results posted on
2010-12-08
Participant Flow
Participant milestones
| Measure |
Losartan/HCTZ (Test) First
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
|
Hyzaar® (Reference) First
100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
10
|
10
|
|
First Intervention
COMPLETED
|
10
|
9
|
|
First Intervention
NOT COMPLETED
|
0
|
1
|
|
Washout of 7 Days
STARTED
|
10
|
9
|
|
Washout of 7 Days
COMPLETED
|
10
|
9
|
|
Washout of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
9
|
|
Second Intervention
COMPLETED
|
10
|
9
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Losartan/HCTZ (Test) First
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
|
Hyzaar® (Reference) First
100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
|
|---|---|---|
|
First Intervention
Adverse Event
|
0
|
1
|
Baseline Characteristics
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Losartan/HCTZ (Test) First
n=10 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
|
Hyzaar® (Reference) First
n=10 Participants
100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Losartan Cmax.
Outcome measures
| Measure |
Losartan/HCTZ (Test)
n=19 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
|
Hyzaar® (Reference)
n=19 Participants
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)
|
509.63 ng/mL
Standard Deviation 314.75
|
538.11 ng/mL
Standard Deviation 298.89
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Losartan AUC0-t.
Outcome measures
| Measure |
Losartan/HCTZ (Test)
n=19 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
|
Hyzaar® (Reference)
n=19 Participants
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
866.88 ng*h/mL
Standard Deviation 366.15
|
865.00 ng*h/mL
Standard Deviation 362.86
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Losartan AUC0-inf.
Outcome measures
| Measure |
Losartan/HCTZ (Test)
n=19 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
|
Hyzaar® (Reference)
n=19 Participants
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)
|
880.15 ng*h/mL
Standard Deviation 368.58
|
877.99 ng*h/mL
Standard Deviation 362.75
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Hydrochlorothiazide Cmax.
Outcome measures
| Measure |
Losartan/HCTZ (Test)
n=19 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
|
Hyzaar® (Reference)
n=19 Participants
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
|
177.63 ng/mL
Standard Deviation 48.09
|
161.56 ng/mL
Standard Deviation 53.75
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Hydrochlorothiazide AUC0-t.
Outcome measures
| Measure |
Losartan/HCTZ (Test)
n=19 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
|
Hyzaar® (Reference)
n=19 Participants
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
1057.58 ng*h/mL
Standard Deviation 231.26
|
1001.54 ng*h/mL
Standard Deviation 236.00
|
PRIMARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Bioequivalence based on Hydrochlorothiazide AUC0-inf.
Outcome measures
| Measure |
Losartan/HCTZ (Test)
n=19 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
|
Hyzaar® (Reference)
n=19 Participants
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)
|
1087.64 ng*h/mL
Standard Deviation 240.82
|
1030.73 ng*h/mL
Standard Deviation 238.96
|
SECONDARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.
Outcome measures
| Measure |
Losartan/HCTZ (Test)
n=19 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
|
Hyzaar® (Reference)
n=19 Participants
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)
|
726.85 ng/mL
Standard Deviation 210.78
|
675.54 ng/mL
Standard Deviation 197.25
|
SECONDARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.
Outcome measures
| Measure |
Losartan/HCTZ (Test)
n=19 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
|
Hyzaar® (Reference)
n=19 Participants
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
|
4236.78 ng*h/mL
Standard Deviation 1176.34
|
4117.07 ng*h/mL
Standard Deviation 1087.67
|
SECONDARY outcome
Timeframe: Blood samples collected over a 48 hour period.Population: All participants that completed the study had their samples analyzed.
Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.
Outcome measures
| Measure |
Losartan/HCTZ (Test)
n=19 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
|
Hyzaar® (Reference)
n=19 Participants
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)
|
4281.32 ng*h/mL
Standard Deviation 1182.77
|
4164.62 ng*h/mL
Standard Deviation 1096.64
|
Adverse Events
Losartan/HCTZ (Test)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Hyzaar® (Reference)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Losartan/HCTZ (Test)
n=20 participants at risk
100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
|
Hyzaar® (Reference)
n=20 participants at risk
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
General disorders
Headache
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
15.0%
3/20 • Number of events 3 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Pharyngitis
|
0.00%
0/20 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.0%
1/20 • Number of events 2 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Sweaty
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
0.00%
0/20 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Purpura
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
0.00%
0/20 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Leg Muscles Tight
|
0.00%
0/20 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Cut Forearm
|
0.00%
0/20 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Fell
|
0.00%
0/20 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
|
General disorders
Confussion
|
0.00%
0/20 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
5.0%
1/20 • Number of events 1 • Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
|
Additional Information
Associate Director, Biopharmaceutics
TEVA Pharmaceuticals, USA
Phone: 1-866-384-5525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator is not permitted to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER