Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg
Information source: Mylan Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Fluoxetine Capsules 40 mg (Drug); Prozac Pulvules 40 mg (Drug)
Phase: Phase 1
Sponsored by: Mylan Pharmaceuticals
Official(s) and/or principal investigator(s):
James D Carlson, Pharm. D., Principal Investigator, Affiliation: PRACS Institute Ltd.
The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine
hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg
(1 x 40 mg) dose administration under fasting conditions.
Official title: Single-Dose Fasting Bioequivalence Study of Fluoxetine Capsules (40 mg; Mylan) and Prozac Pulvules (40 mg; Dista) in Healthy Adult Volunteers
Study design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Minimum age: 18 Years.
Maximum age: N/A.
1. Age: 18 years and older.
2. Sex: Male and/or non-pregnant, non-lactating female. a. Women of childbearing
potential must have negative serum beta human chorionic gonadotropin (b-HCG) pregnancy
tests performed within 21 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 (b-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 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. c. Women will not be considered of childbearing potential if one of the
following is reported and documented on the medical history: 1) postmenopausal with an
absence of menses for at least one 2) bilateral oophorectomy with or without a
hysterectomy and 3) total hysterectomy d. During the course of the study, from study
screen until study exit, all men and women of childbearing potential must use a
spermicide-containing barrier method of contraception in addition to their current
contraceptive device. This requirement should be documented in the informed consent
3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women with all
subjects having a Body Mass Index (BMI) less than or equal to 30 but greater than or
equal to 19. (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, cannabinoid, cocaine, opiates, phencyclidine, and methadone)
performed within 21 days of the initial dose of study medication.
1. Institutionalized subjects will not be used.
2. Social Habits: a. Use of any tobacco products within one year prior to dosing. 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 or herbal products within 7 days prior to the initial dose of the study
medication. d. Any recent, significant change in dietary or exercise habits. e. A
positive test for any drug included in the urine drug screen. f. History of drug
and/or alcohol abuse.
3. Medications: a. Use of any prescription or over-the-counter (OTC) medications within
the 14 days prior to the initial dose of study medication, especially any monoamine
oxidase inhibitor (MAOI). b. Use of any hormonal contraceptives and hormone
replacement therapy within 3 months prior to study medication dosing. c. Use of any
medication known to alter hepatic enzyme activity within 35 days prior to the initial
dose of study medication.
4. Diseases: a. History of any significant cardiovascular, hepatic, renal, pulmonary,
hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic
disease. b. Acute illness at the time of either the pre-study medical evaluation or
dosing. c. A positive HIV, Hepatitis B, or Hepatitis C test. d. History of seizures or
any psychiatric disorders.
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 fluoxetine, any of the inactive ingredients, or other
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
Locations and Contacts
PRACS Institute, Ltd., Fargo, North Dakota 58104, United States
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Last updated: March 31, 2008