Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Mylan Pharmaceuticals |
---|---|
Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00649181 |
The objective of this study was to investigate the bioequivalence of Mylan metolazone 5 mg tablets to Celltech Zaroxolyn® 5 mg tablets following a single, oral 10 mg (2 x 5 mg) dose administration under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Metolazone Tablets 5 mg Drug: Zaroloxyn® Tablets 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 (5 mg; Mylan) and Zaroloxyn® Tablets (5 mg; Celltech) in Healthy Volunteers |
Enrollment: | 52 |
Study Start Date: | October 2003 |
Study Completion Date: | November 2003 |
Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Metolazone Tablets 5 mg
|
Drug: Metolazone Tablets 5 mg
2x5mg, single dose fasting
|
2: Active Comparator
Zaroloxyn® Tablets 5 mg
|
Drug: Zaroloxyn® Tablets 5 mg
2x5mg, single dose fasting
|
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:
a. History of any significant chronic disease and/or hepatitis. b. History of drug and/or alcohol abuse. d. Acute illness at the time of either the pre-study medical evaluation or dosing.
e. A positive HIV, Hepatitis B, or Hepatitis C test result.
Abnormal and clinically significant laboratory test results:
United States, West Virginia | |
Kendle International Inc. | |
Morgantown, West Virginia, United States, 26505 |
Principal Investigator: | Thomas S Clark, M.D. | Kendle International Inc. |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | METO-0361 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00649181 |
Health Authority: | United States: Institutional Review Board |
Metolazone Healthy |
Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs Diuretics |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |