NCT00913965

CompletedPhase 1

To Demonstrate the Relative Bioavailability of Atenolol Tabl...

Sandoz Source

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Other study identifiers

Sponsor study identifier

9103B

Study Type

interventional

Actual enrollment (reported)

24

Locations

0 countries

Sites

N/A

Timeline

Study Start

July 1989

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 1989

Actual (reported)

Study Completion

August 1989

Actual (reported)

Brief Summary

To demonstrate the relative bioavailability of Atenolol tablets.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 24 participants
Study completion date: August 1989
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 1989
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
August 1989
Actual (reported)
Study Completion
August 1989
Actual (reported)
First Submitted
June 2, 2009
Actual (reported)
First Posted
June 4, 2009
Actual (reported)

Last Updated: March 28, 2017
Status Verified: June 2009
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

Sandoz
Industrylead

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

Enrollment

24 participants (actual enrollment reported by the registry).

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 1989

Date type not reported

This date has not been verified as actual or estimated.

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Positive test results for HIV or hepatitis B or C.

Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Primary Completion

August 1989

Actual (reported)

Study Completion

August 1989

Actual (reported)

Last Updated

March 28, 2017

Record last verified: 2009-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00913965
Data provider: ClinicalTrials.gov
Source updated: 2017-03-28
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:13 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record