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| Sponsored by: |
Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649051 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan metolazone 2.5 mg tablets to Celltech Zaroxolyn® 2.5 mg tablets following a single, oral 10 mg (4 x 2.5 mg) dose administration under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Metolazone Tablets 2.5 mg Drug: Zaroloxyn® Tablets 2.5 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 (2.5 mg; Mylan) and Zaroloxyn® Tablets (2.5 mg; Celltech) in Healthy Volunteers |
| Enrollment: | 52 |
| Study Start Date: | December 2002 |
| Study Completion Date: | January 2003 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Metolazone Tablets 2.5 mg
|
Drug: Metolazone Tablets 2.5 mg
4x2.5mg, single dose fasting
|
|
2: Active Comparator
Zaroloxyn® Tablets 2.5 mg
|
Drug: Zaroloxyn® Tablets 2.5 mg
4x2.5mg, 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.
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, Missouri | |
| Gateway Medical Research, Inc. | |
| St. Charles, Missouri, United States, 63301 | |
| Principal Investigator: | Thomas Siler, M.D. | Cetero Research |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | METO-02110 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649051 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Metolazone Diuretics Cardiovascular Agents Healthy Antihypertensive Agents |
|
Metolazone Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Diuretics Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |