To Demonstrate the Relative Bioavailability of Atenolol T... | NCT00946725

Studies
To Demonstrate the Relative Bioavailability of Atenolol Tablets, 100 mg

NCT00946725

Sponsor

Sandoz

Status

Completed

Last Update Posted

Mar 28, 2017Actual

Enrollment

28Actual

Phase

Phase 1

Conditions

Angina
Hypertension

Interventions

Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)
Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2000

Primary Completion Date

Nov 2000Actual

Completion Date

Nov 2000Actual

First Submitted Date

Jul 24, 2009

First Submission Date that Met QC Criteria

Jul 24, 2009

First Posted Date

Jul 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2017

Last Update Posted Date

Mar 28, 2017Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)	Drug: Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)
2	Active Comparator	Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)	Drug: Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atenolol (Tenormin) 100 mg Tablets Zeneca (Astra Zeneca Pharmaceutical)	Drug		2
Atenolol 100 mg Tablets (Geneva Pharmaceutical, Inc.)

Measure	Description	Time Frame
Bioequivalence based on AUC and Cmax		20 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronald Goldwater, M.D.	PharmaKinetics Laboratories Inc.	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000787	Angina Pectoris
D006973	Hypertension
D002637	Chest Pain

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001262	Atenolol

Ancestor Terms

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided