CClinicalTrials.gg
CompletedNCT00883064Updated Mar 29, 2017

To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting Conditions

A Phase 1 interventional study of Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA) and Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA) in Hypertension, sponsored by Sandoz. Completed. Open to male participants aged 18 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-29.

Sponsored by Sandoz · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 54 Years
Sex
Male
01

Study summary

To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting Conditions.

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 32 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

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Lead sponsor

Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 54 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion criteria

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.
05

Study design

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

Study arms

  • Experimental
    1

    Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)

    Drug: Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)

  • Active comparator
    2

    Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)

    Drug: Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)

Interventions

  • DrugLisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)
  • DrugLisinopril 40 mg Tablet (Zestril) (Zeneca, USA)
06

What researchers measure

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 23 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00883064
Lead sponsor
Sandoz
First posted
Apr 17, 2009
Start date
Mar 2000
Primary completion
Apr 2000
Completion
Apr 2000
Last update
Mar 29, 2017

Study contacts

Eric Masson, Pharm.D.
principal investigator · Anapharm
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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