NCT00960245

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 1994

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, 1994

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 1994

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1994

Completed
15.1 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
Last Updated

March 28, 2017

Status Verified

August 1, 2009

Enrollment Period

Same day

First QC Date

August 13, 2009

Last Update Submit

March 27, 2017

Conditions

High Blood PressureMigraine HeadachesChest Pain

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    21 days

Study Arms (2)

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

Nadolol (1 x 80 mg) Tablets (Invamed, Inc)DRUG
1
Corgard (1 x 80 mg) Tablets (Bristol Laboratories)DRUG
2

Eligibility Criteria

Age18 Years - 40 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

HypertensionMigraine DisordersChest Pain

Interventions

Nadolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Terry L. Wolff, D.O.

    MeritCare Broadway Health Center

    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

August 13, 2009

First Posted

August 17, 2009

Study Start

July 1, 1994

Primary Completion

July 1, 1994

Study Completion

July 1, 1994

Last Updated

March 28, 2017

Record last verified: 2009-08