Trial Outcomes & Findings for Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions (NCT NCT01149473)
NCT ID: NCT01149473
Last Updated: 2024-08-20
Results Overview
Bioequivalence based on Losartan Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
Blood samples collected over a 48 hour period.
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Losartan/HCTZ (Test) First
100/25 mg Losartan potassium/Hydrochlorothiazide 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 test product dosed in the second period.
|
|---|---|---|
|
First Intervention
STARTED
|
40
|
40
|
|
First Intervention
COMPLETED
|
39
|
39
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Washout of 7 Days
STARTED
|
39
|
39
|
|
Washout of 7 Days
COMPLETED
|
38
|
38
|
|
Washout of 7 Days
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
38
|
38
|
|
Second Intervention
COMPLETED
|
38
|
38
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Losartan/HCTZ (Test) First
100/25 mg Losartan potassium/Hydrochlorothiazide 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 test product dosed in the second period.
|
|---|---|---|
|
First Intervention
Adverse Event
|
1
|
1
|
|
Washout of 7 Days
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions
Baseline characteristics by cohort
| Measure |
Losartan/HCTZ (Test) First
n=40 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
|
Hyzaar® (Reference) First
n=40 Participants
100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in the second period.
|
Total
n=80 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
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 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=76 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
|
Hyzaar® (Reference)
n=76 Participants
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)
|
458.29 ng/mL
Standard Deviation 323.345
|
409.324 ng/mL
Standard Deviation 251.876
|
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=76 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
|
Hyzaar® (Reference)
n=76 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)
|
959.41 ng*h/mL
Standard Deviation 480.988
|
939.492 ng*h/mL
Standard Deviation 465.001
|
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=76 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
|
Hyzaar® (Reference)
n=76 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)
|
957.445 ng*h/mL
Standard Deviation 465.781
|
956.046 ng*h/mL
Standard Deviation 467.567
|
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=76 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
|
Hyzaar® (Reference)
n=76 Participants
100/25 mg Hyzaar® Tablets reference product dosed in either period.
|
|---|---|---|
|
Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
|
136.361 ng/mL
Standard Deviation 33.311
|
132.717 ng/mL
Standard Deviation 35.468
|
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=76 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
|
Hyzaar® (Reference)
n=76 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)
|
917.034 ng*h/mL
Standard Deviation 212.109
|
919.631 ng*h/mL
Standard Deviation 210.684
|
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=76 Participants
100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
|
Hyzaar® (Reference)
n=76 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)
|
943.22 ng*h/mL
Standard Deviation 217.842
|
945.592 ng*h/mL
Standard Deviation 217.269
|
Adverse Events
Losartan/HCTZ (Test)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hyzaar® (Reference)
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
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