- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00649051
Fasting Study of Metolazone Tablets 2.5 mg and Zaroloxyn® Tablets 2.5 mg
March 31, 2008 updated by: Mylan Pharmaceuticals Inc
Single-Dose Fasting In Vivo Bioequivalence Study of Metolazone Tablets (2.5 mg; Mylan) and Zaroloxyn® Tablets (2.5 mg; Celltech) in Healthy Volunteers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
St. Charles, Missouri, United States, 63301
- Gateway Medical Research, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 18 years and older
Sex: Male and/or non-pregnant, non-lactating female
- Women of childbearing potential must have negative serum (β-HCG) pregnancy tests performed within 14 days prior to the start of the study and within 72 hours prior to the start of dosing for each treatment period. An additional serum (β-HCG) pregnancy test will be performed upon completion of the study.
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:
- intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
- barrier methods containing or used in conjunction with a spermicidal agent, or
- surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a postmenopausal course of at least one year, as documented on the subject's medical history.
- During the course of the study, from study screen until study exit - including the washout period, males must use a spermicide-containing barrier method of contraception to prevent the pregnancy of their sexual partner. This advice should be documented in the informed consent form.
- Weight: At least 60 kg (132 lbs.) for men and 48 kg (106 lbs.) for women and within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, Hepatitis B, Hepatitis C and HIV tests, and urine drug screen including amphetamine, benzodiazepine, cannabinoid, cocaine, opiate screen, and phencyclidine) performed within 14 days of the initial dose of study medication.
Exclusion Criteria:
- Institutionalized subjects will not be used.
Social Habits:
- Use of any tobacco products within one year prior to dosing.
- Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
- Any recent, significant change in dietary or exercise habits.
Medications:
- Use of any medication within the last 14 days prior to the initial dose of study medication, including the use of oral contraceptives, hormone replacement therapy, and over-the-counter medications.
- Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
Diseases:
- History of any significant chronic disease and/or hepatitis.
- History of drug and/or alcohol abuse.
- Acute illness at the time of either the pre-study medical evaluation or dosing.
- A positive HIV, Hepatitis B, or Hepatitis C test result.
Abnormal and clinically significant laboratory test results:
- Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- Abnormal and clinically relevant ECG tracing.
- Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
- Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- Allergy or hypersensitivity to metolazone, sulfonamide-derived drugs, thiazides, quinethazone or other related products.
- History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- Consumption of grapefruit or grapefruit containing products within 48 hours of drug administration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Metolazone Tablets 2.5 mg
|
4x2.5mg, single dose fasting
|
Active Comparator: 2
Zaroloxyn® Tablets 2.5 mg
|
4x2.5mg, single dose fasting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence
Time Frame: within 30 days
|
within 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Primary Completion (Actual)
December 1, 2002
Study Completion (Actual)
January 1, 2003
Study Registration Dates
First Submitted
March 30, 2008
First Submitted That Met QC Criteria
March 31, 2008
First Posted (Estimate)
April 1, 2008
Study Record Updates
Last Update Posted (Estimate)
April 1, 2008
Last Update Submitted That Met QC Criteria
March 31, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METO-02110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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