NCT00946465

Brief Summary

To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under fasting conditions.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 hypertension

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_1 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

March 28, 2017

Status Verified

July 1, 2009

Enrollment Period

1 month

First QC Date

July 24, 2009

Last Update Submit

March 27, 2017

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    30 days

Study Arms (2)

1

EXPERIMENTAL

Ramipril 10 Capsule (Sandoz)

Drug: Ramipril 10 Capsule (Sandoz)

2

ACTIVE COMPARATOR

Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)

Drug: Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)

Interventions

Ramipril 10 Capsule (Sandoz)DRUG
1
Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)DRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Steven Herrmann, M.D., PhD

    Cetero Research, San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

October 1, 2004

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

March 28, 2017

Record last verified: 2009-07