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| Sponsored by: |
Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00650195 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan metolazone 10 mg tablets to Celltech Zaroxolyn® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose administration under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Metolazone Tablets 10 mg Drug: Zaroloxyn® Tablets 10 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Metolazone Tablets (10 mg; Mylan) and Zaroloxyn® Tablets (10 mg; Celltech) in Healthy Volunteers |
| Enrollment: | 56 |
| Study Start Date: | February 2004 |
| Study Completion Date: | March 2004 |
| Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Metolazone Tablets 10 mg
|
Drug: Metolazone Tablets 10 mg
10mg, single dose fasting
|
|
2: Active Comparator
Zaroloxyn® Tablets 10 mg
|
Drug: Zaroloxyn® Tablets 10 mg
10mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female
Women of childbearing potential must practice abstinence or use an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | METO-0409 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00650195 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Metolazone Diuretics Cardiovascular Agents Healthy Antihypertensive Agents |
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Metolazone Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Diuretics Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |