NCT00913965

Brief Summary

To demonstrate the relative bioavailability of Atenolol tablets.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_1 hypertension

Timeline
Completed

Started Jul 1989

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1989

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 1989

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1989

Completed
19.8 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
Last Updated

March 28, 2017

Status Verified

June 1, 2009

Enrollment Period

1 month

First QC Date

June 2, 2009

Last Update Submit

March 27, 2017

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    11 days

Study Arms (2)

1

EXPERIMENTAL

Atenolol Tablets 100 mg (Cord Laboratories)

Drug: Atenolol Tablets 100 mg (Cord Laboratories)

2

ACTIVE COMPARATOR

Atenolol Tablets 100 mg (Stuart Pharmaceutical)

Drug: Atenolol Tablets 100 mg (Stuart Pharmaceutical)

Interventions

Atenolol Tablets 100 mg (Cord Laboratories)DRUG
1
Atenolol Tablets 100 mg (Stuart Pharmaceutical)DRUG
2

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Atenolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Rudolph C. Cane, Jr., M.D.

    PharmaKinetics Laboratories Inc.

    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

June 2, 2009

First Posted

June 4, 2009

Study Start

July 1, 1989

Primary Completion

August 1, 1989

Study Completion

August 1, 1989

Last Updated

March 28, 2017

Record last verified: 2009-06