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CompletedNCT00953680Updated Feb 9, 2022Results posted

Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)

A Phase 1 interventional study of losartan potassium (+) hydrochlorothiazide (HCTZ) and losartan potassium in Hypertension, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by Organon and Co · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 77 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject is a healthy male or female between the ages of 18 and 45 years of age
  • Subject does not smoke

Exclusion criteria

Exclusion Criteria:

  • Subject has a history of any illness that might pose additional risk to participation or confound the results of the study
  • Subject has a history of hepatitis B or C or significant drug allergies
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
77 participants (actual)

Study arms

  • Active comparator
    losartan /HCTZ combination tablet

    single dose losartan 100 mg/HCTZ 12.5 mg combination tablet

    Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)

  • Active comparator
    losartan tablet + HCTZ capsule

    Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule

    Drug: losartan potassium · Drug: hydrochlorothiazide (HCTZ)

Interventions

  • Druglosartan potassium (+) hydrochlorothiazide (HCTZ)

    Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.

  • Druglosartan potassium

    Single dose losartan 100 mg tablet in one of two treatment periods.

    Also known as: COZAAR™

  • Drughydrochlorothiazide (HCTZ)

    Single dose HCTZ 12.5 mg capsule in one of two treatment periods.

    Also known as: MICROZIDE™

06

What researchers measure

Primary outcomes

  1. Area Under the Curve (AUC(0 to Infinity)) of Losartan

    Time frame: 0 to 36 Hours Post Dose

  2. Peak Plasma Concentration (Cmax) for Losartan

    Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.

    Time frame: 36 Hours Post Dose

  3. Area Under the Curve (AUC(0 to Infinity)) of HCTZ

    Plasma Area Under the Curve, a measure of drug exposure following dosing

    Time frame: 0 to 30 Hours Post Dose

  4. Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ

    Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing

    Time frame: 30 Hours Post Dose

07

Results

Posted Jul 16, 2010
Limitations and caveats
PK analyses included complete data from 75 subjects. 3 losartan/E-3174 concentrations from 3 different subjects were excluded from analyses due to gross deviations; 75 minutes-Treatment B, 75 minutes-Treatment A, \& 15 minutes-Treatment A.

Participant flow

Period 1
Participant flow — Period 1
MilestoneLosartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ CapsuleLosartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet
Started3839
Completed3838
Not completed01
Withdrew: Withdrawal by subject01
Period 2
Participant flow — Period 2
MilestoneLosartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ CapsuleLosartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet
Started3838
Completed3838
Not completed00

Outcome measures

PrimaryArea Under the Curve (AUC(0 to Infinity)) of Losartan
Time frame:
0 to 36 Hours Post Dose
Reported as:
Least squares mean · ng*hr/mL
Area Under the Curve (AUC(0 to Infinity)) of Losartan
ng*hr/mLLosartan-HCTZ Combination TabletLosartan Tablet + HCTZ Capsule
Area Under the Curve (AUC(0 to Infinity)) of Losartan1018.1 ± 382.51024.9 ± 354.6
Statistical analysis
  • Losartan-HCTZ Combination Tablet vs Losartan Tablet + HCTZ Capsule · Least-squares mean ratio: 0.993 · 90% CI 0.950 to 1.039
PrimaryPeak Plasma Concentration (Cmax) for Losartan

Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.

Time frame:
36 Hours Post Dose
Reported as:
Least squares mean · ng/mL
Peak Plasma Concentration (Cmax) for Losartan
ng/mLLosartan-HCTZ Combination TabletLosartan Tablet + HCTZ Capsule
Peak Plasma Concentration (Cmax) for Losartan532.7 ± 334.9637.9 ± 425.3
Statistical analysis
  • Losartan-HCTZ Combination Tablet vs Losartan Tablet + HCTZ Capsule · Least-squares mean ratio: 0.835 · 90% CI 0.749 to 0.931
PrimaryArea Under the Curve (AUC(0 to Infinity)) of HCTZ

Plasma Area Under the Curve, a measure of drug exposure following dosing

Time frame:
0 to 30 Hours Post Dose
Reported as:
Least squares mean · ng*hr/mL
Area Under the Curve (AUC(0 to Infinity)) of HCTZ
ng*hr/mLLosartan-HCTZ Combination TabletLosartan Tablet + HCTZ Capsule
Area Under the Curve (AUC(0 to Infinity)) of HCTZ462.08 ± 144.72499.90 ± 133.46
Statistical analysis
  • Losartan-HCTZ Combination Tablet vs Losartan Tablet + HCTZ Capsule · Least-squares mean ratio: 0.924 · 90% CI 0.825 to 1.035
PrimaryPeak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ

Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing

Time frame:
30 Hours Post Dose
Reported as:
Least squares mean · ng/mL
Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ
ng/mLLosartan-HCTZ Combination TabletLosartan Tablet + HCTZ Capsule
Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ76.15 ± 39.5581.76 ± 31.05
Statistical analysis
  • Losartan-HCTZ Combination Tablet vs Losartan Tablet + HCTZ Capsule · Least-squares mean ratio: 0.931 · 90% CI 0.836 to 1.037

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule—0/38 (0%)12/76 (15.8%)
Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet—0/39 (0%)10/77 (13%)
Most frequent other events
Most frequent other events
EventLosartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ CapsuleLosartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet
HeadacheNervous system disorders8/766/77
DizzinessNervous system disorders5/763/77
VomitingGastrointestinal disorders1/761/77
Alanine Aminotransferase IncreasedInvestigations1/760/77
Aspartate Aminotransferase IncreasedInvestigations1/760/77
NauseaGastrointestinal disorders0/761/77

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Participants
Mean33.87 (18 to 45)
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female46
Male31
Height
Height(Centimeters)All Participants
Mean166.81 (152 to 191)
Weight
Weight(kilograms)All Participants
Mean73.01 (50 to 99.1)
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00953680
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Aug 6, 2009
Start date
Apr 2004
Primary completion
May 2004
Completion
Jul 2004
Results posted
Jul 16, 2010
Last update
Feb 9, 2022

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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