Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mg
Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Loxapine Succinate Capsules 25 mg (Drug); Loxitane® Capsules 25 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Pharmaceuticals Official(s) and/or principal investigator(s): Thomas S Clark, M.D., Principal Investigator, Affiliation: Kendle International Inc.
Summary
The objective of this study was to investigate the bioequivalence of Mylan loxapine
succinate 25 mg capsules to Watson Loxitane 25 mg capsules following a single, oral 25 mg (1
x 25 mg) dose administration under fasting conditions.
Clinical Details
Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Loxapine Succinate Capsules (25 mg; Mylan) and Loxitane® Capsules (25 mg; Watson) 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 non-pregnant, non-lactating female a. Women of childbearing potential
must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to
the start of the study and on the evening prior to each dose administration. An
additional serum (Beta HCG) pregnancy test will be performed upon completion of the
study. b. 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 hormonal 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. c. 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 man 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).
4. All subjects should be judged normal and healthy during a pre-study medical
evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and
hepatitis C tests, HIV test, and urine drug screen including amphetamine,
barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, 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: a. Use of any tobacco products. b. Ingestion of any alcoholic,
caffeine- or xanthine-containing food or beverage within the 48 hours prior to the
initial dose of study medication. c. Ingestion of any vitamins within the 48 hours
prior to the initial dose of the study medication. d. Any recent, significant change
in dietary or exercise habits.
3. Medications: a. Use of any medication within the 14 days prior to the initial dose of
study medication. b. Use of any medication known to alter hepatic enzyme activity
within 28 days prior to the initial dose of study medication.
4. Diseases: a. History of any significant chronic disease and/or hepatitis. b. History
of drug and/or alcohol abuse.
5. Abnormal and clinically significant laboratory test results: a. Clinically
significant deviation from the Guide to Clinically Relevant Abnormalities (See Part
II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). b. 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 Loxitane, any of the inactive ingredients, or 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
Kendle International Inc., Morgantown, West Virginia 26505, 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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