Relative Bioavailability Study of Nadolol (1 x 80 mg) Tab... | NCT00960245

Studies
Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions

NCT00960245

Sponsor

Sandoz

Status

Completed

Last Update Posted

Mar 28, 2017Actual

Enrollment

34Actual

Phase

Phase 1

Conditions

High Blood Pressure
Migraine Headaches
Chest Pain

Interventions

Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
Corgard (1 x 80 mg) Tablets (Bristol Laboratories)

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

Aug 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

Jul 1994

Primary Completion Date

Jul 1994Actual

Completion Date

Jul 1994Actual

First Submitted Date

Aug 13, 2009

First Submission Date that Met QC Criteria

Aug 14, 2009

First Posted Date

Aug 17, 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

Description Module

Brief Summary

The purpose of this study is to demonstrate the relative bioavailability of Nadolol (1 x 80 mg) tablets under fasting conditions.

Detailed Description

Not provided

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

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Nadolol (1 x 80 mg) Tablets (Invamed, Inc)	Drug: Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
2	Active Comparator	Corgard (1 x 80 mg) Tablets (Bristol Laboratories)	Drug: Corgard (1 x 80 mg) Tablets (Bristol Laboratories)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nadolol (1 x 80 mg) Tablets (Invamed, Inc)	Drug		1
Corgard (1 x 80 mg) Tablets (Bristol Laboratories)

Measure	Description	Time Frame
Bioequivalence based on AUC and Cmax		21 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

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Terry L. Wolff, D.O.	MeritCare Broadway Health Center	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D008881	Migraine Disorders
D002637	Chest Pain

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D051270	Headache Disorders, Primary
D020773	Headache Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009248	Nadolol

Ancestor Terms

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided