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| Sponsor: | Par Pharmaceutical, Inc. |
|---|---|
| Collaborator: |
SFBC Anapharm |
| Information provided by: | Par Pharmaceutical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00653120 |
Purpose
To compare the single-dose bioavailability of Propranolol 160 Mg ER capsules with Inderal-La
| Condition | Intervention | Phase |
|---|---|---|
|
To Determine Bioequivalence Under Fasting Conditions |
Drug: Propranolol Drug: Inderal-LA |
Phase II |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment |
| Official Title: | Comparative, Randomized, Single-Dose, 2 Way Cross Over Bioavailability Study of Par Propranolol 160 mg With That of Inderal-LA Propranolol 160 mg in Healthy Subjects Under Fasting Conditions. |
| Enrollment: | 48 |
| Study Start Date: | May 2005 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Subjects received Par Products under fasting conditions
|
Drug: Propranolol
ER capsules, 160 mg, single-dose
|
|
B: Active Comparator
Subjects received Wyeth Pharmaceuticals product under fasting conditions
|
Drug: Inderal-LA
ER capsules, 160 mg, single-dose
|
To compare the single -dose bioavailability of Par Propranolol 160 Mg ER capsules with Wyeth Pharmaceuticals, Inderal-LA, Propranolol under fasting conditions.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Par Pharmaceutical, Inc. ( Dr. Alfred Elvin/ Director Biopharmaceutics ) |
| Study ID Numbers: | 40451 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00653120 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Bioequivalence, Propranolol ER capsules, fasting |
|
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Propranolol Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents |