Fed Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin� Capsules 1 mg
Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Anagrelide Hydrochloride Capsules 1 mg (Drug); Agrylin® Capsules 1 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Pharmaceuticals Official(s) and/or principal investigator(s): James Carlson, Pharm. D., Principal Investigator, Affiliation: PRACS Institute Ltd.
Summary
The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl
1 mg capsules to Shire US's Agrylin® 1 mg capsules following a single, oral 1 mg (1 x 1 mg)
dose administration under fed conditions.
Clinical Details
Official title: Single-Dose Food In Vivo Bioequivalence Study of Anagrelide Hydrochloride Capsules (1 mg; Mylan) to Agrylin® Capsules (1 mg; Shire US) in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age: 18 years and older.
2. Sex: Male and/or non-pregnant, non-lactating female.
1. Women of childbearing potential must have negative serum beta-human chorionic
gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the
start of the study and on the evening prior to each dose administration. If
dosing is scheduled on weekends, the HCG pregnancy test should be given within
48 hours prior to dosing of each study period. An additional serum (beta-HCG)
pregnancy test will be performed upon completion of the study.
2. Women of childbearing potential must practice abstinence or be using an
acceptable form of contraception throughout the duration of the study. No
hormonal contraceptives or hormone replacement therapy are permitted in this
study. Acceptable forms of contraception include the following:
1. 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
2. barrier methods containing or used in conjunction with a spermicidal agent,
or
3. surgical sterility (tubal ligation, oophorectomy or hysterectomy) or
postmenopausal accompanied with a documented postmenopausal course of at
least one year.
3. During the course of the study, from study screen until study exit - including
the washout period, women of childbearing potential must use a spermicide
containing barrier method of contraception in addition to their current
contraceptive device. This advice should be documented in the informed consent
form.
3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all
subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of
"Desirable Weights of Adults" Metropolitan Life Insurance Company, 1983 (See Part II
ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
4. All subjects should be judged normal and healthy during a pre-study medical
evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C
tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine,
barbiturates, benzodiazepines, cannabinoids, cocaine, opiate screen, phencyclidine,
and methadone) performed within 14 days of the initial dose of study medication.
Exclusion Criteria:
1. Institutionalized subjects will not be used.
2. Social Habits:
1. Use of any tobacco products within 1 year of the start of the study.
2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage
within the 48 hours prior to the initial dose of study medication.
3. Ingestion of any vitamins or herbal products within the 48 hours prior to the
initial dose of the study medication.
4. Any recent, significant change in dietary or exercise habits.
5. A positive test for any drug included in the urine drug screen.
6. History of drug and/or alcohol abuse within 1 year of the start of the study.
3. Medications:
1. Use of any medication [including over-the-counter (OTC)] within the 14 days
prior to the initial dose of study medication. Hormonal contraceptives and
hormone replacement therapy should NOT be used within 3 months prior to study
medication dosing.
2. Use of any medication known to alter hepatic enzyme activity within 28 days
prior to the initial dose of study medication.
3. History of using psychotropic agents within 12 months prior to the initial dose
of study medication.
4. Diseases:
1. History of any significant cardiovascular, hepatic, renal, pulmonary,
hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic
disease.
2. Acute illness at the time of either the pre-study medical evaluation or dosing.
5. Abnormal and clinically significant laboratory test results:
1. Clinically significant deviation from the Guide to Clinically Relevant
Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
2. Abnormal and clinically relevant ECG tracing.
6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days
prior to the initial dose of study medication.
7. Subjects who have received an investigational drug within 30 days prior to the
initial dose of study medication.
8. Allergy or hypersensitivity to anagrelide or any other related products
9. History of difficulties in swallowing, or any gastrointestinal disease which could
affect the drug absorption.
10. Consumption of grapefruit or grapefruit containing products within 7 days of drug
administration.
Locations and Contacts
PRACS Institute, Ltd., Fargo, North Dakota 58104, United States
Additional Information
Mylan Pharmaceuticals Inc. - Clinical Trial Results Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use Recalls, Market Withdrawals and Safety Alerts FDA Enforcement Report Index Medwatch, FDA Safety Information and Adverse Event Reporting Program
Starting date: January 2003
Last updated: March 31, 2008
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