Back to resultsRelative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions
Primary Purpose
High Blood Pressure, Migraine Headaches, Chest Pain
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
Corgard (1 x 80 mg) Tablets (Bristol Laboratories)
Sponsored by
About this trial
This is an interventional treatment trial for High Blood Pressure
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
Corgard (1 x 80 mg) Tablets (Bristol Laboratories)
Outcomes
Primary Outcome Measures
Bioequivalence based on AUC and Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00960245
Brief Title
Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions
Official Title
A Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
July 1994 (undefined)
Primary Completion Date
July 1994 (Actual)
Study Completion Date
July 1994 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to demonstrate the relative bioavailability of Nadolol (1 x 80 mg) tablets under fasting conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure, Migraine Headaches, Chest Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Corgard (1 x 80 mg) Tablets (Bristol Laboratories)
Intervention Type
Drug
Intervention Name(s)
Nadolol (1 x 80 mg) Tablets (Invamed, Inc)
Intervention Type
Drug
Intervention Name(s)
Corgard (1 x 80 mg) Tablets (Bristol Laboratories)
Primary Outcome Measure Information:
Title
Bioequivalence based on AUC and Cmax
Time Frame
21 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry L. Wolff, D.O.
Organizational Affiliation
MeritCare Broadway Health Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions
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