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| Sponsor: | Par Pharmaceutical, Inc. |
|---|---|
| Collaborator: |
Anapharm |
| Information provided by: | Par Pharmaceutical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00653549 |
Purpose
To compare the single-dose bioavailability of Torsemide tablets with Demadex
| Condition | Intervention | Phase |
|---|---|---|
|
To Determine Bioequivalence Under Fasting Conditions |
Drug: Torsemide Drug: Demadex |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Comparative, Randomized, Single-Dose, 2 Way Cross Over Bioavailability Study of Par Torsemide Tablets 20mg With That of Roche Demadex 1*20 mg in Healthy Subjects Under Fasting Conditions. |
| Enrollment: | 26 |
| Study Start Date: | April 2001 |
| Study Completion Date: | May 2001 |
| Primary Completion Date: | May 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Subjects received Par formulated product under fasting conditions
|
Drug: Torsemide
Tablets, 20 mg, single-dose
Other Name: Demadex
|
|
Active Comparator: B
Subjects received Roche formulated product under fasting conditions
|
Drug: Demadex
tablets, 20 mg, single-dose
Other Name: Torsemide
|
To compare the single -dose bioavailability of Par Torsemide tablets 20mg with that Roche Demadex 1*20mg tablets under fasting conditions.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects enrolled in the study will be members of the community at large.
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Dr. Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00653549 History of Changes |
| Other Study ID Numbers: | 01169 |
| Study First Received: | April 1, 2008 |
| Last Updated: | June 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Bioequivalence Torsemide Tablets fasting |
|
Disease Pathologic Processes Torsemide Diuretics Natriuretic Agents |
Physiological Effects of Drugs Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |