90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions

• ClinicalTrials.gov Identifier: NCT01247272
• Recruitment Status: Completed
• First Posted: November 24, 2010
• Results First Posted: February 21, 2011
• Last Update Posted: February 21, 2011
• Sponsor: Teva Pharmaceuticals USA
• Information provided by: Teva Pharmaceuticals USA

Study Description

Brief Summary:

This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company following a single oral dose (1 x 90 mg) in healthy adult volunteers under fasting conditions.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Fluoxetine Hydrochloride; Drug: PROZAC WEEKLY®	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Relative Bioavailability Study of 90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions
• Study Start Date: May 2001
• Actual Primary Completion Date: July 2001
• Actual Study Completion Date: July 2001

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Reference Listed Drug; 90 mg PROZAC WEEKLY® Capsules (Eli Lilly)	Drug: PROZAC WEEKLY®; 90 mg Capsules; Other Name: Fluoxetine Hydrochloride (generic name)
Experimental: Investigational Test Product; 90 mg Fluoxetine Hydrochloride Capsules (Teva)	Drug: Fluoxetine Hydrochloride; 90 mg Capsules

Outcome Measures

Primary Outcome Measures :

1. Cmax of Fluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ]
   Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).
2. AUC0-t of Fluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ]
   Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
3. AUC0-inf of Fluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ]
   Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).

Secondary Outcome Measures :

1. Cmax of Norfluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ]
   Informational comparison of Cmax values for the metabolite Norfluoxetine.
2. AUC0-t of Norfluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ]
   Informational comparison of AUC0-t values for the metabolite Norfluoxetine.
3. AUC0-inf of Norfluoxetine. [ Time Frame: Blood samples collected over a 25 day period. ]
   Bioequivalence based on Norfluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Screening Demographics: All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The weight range will not exceed + 15% for height and body frame as per Desirable Weights for Men - 1983 Metropolitan Height and Weight Table or Desirable Weights for Women - 1983 Metropolitan Height and Weight Table.
• Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.

• If female and:

  • Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), or
  • Is postmenopausal for at least 1 year, or
  • Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

• Volunteers with a recent history of drug or alcohol addiction or abuse.
• Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
• Volunteers whose clinical laboratory test values are outside the acceptable reference range and when confirmed on re-examination are deemed to be clinically significant.
• Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
• Volunteers demonstrating a positive drug abuse screen when screened for this study.
• Female volunteers demonstrating a positive pregnancy screen.
• Female volunteers who are currently breastfeeding.
• Volunteers with a history of allergic response(s) to fluoxetine or related drugs.
• Volunteers with a history of clinically significant allergies including drug allergies.
• Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
• Volunteers who currently use tobacco products.
• Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.
• Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate blood for 4 weeks after completing the study.
• Volunteers who have donated plasma within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for 4 weeks after completing the study.
• Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
• Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing.

Contacts and Locations

Locations

United States, North Dakota

PRACS Institute, Ltd.

Fargo, North Dakota, United States, 58102

Sponsors and Collaborators

Teva Pharmaceuticals USA

Investigators

• Principal Investigator: James D Carlson, Pharm.D.; PRACS Institute, Ltd.

More Information

• ClinicalTrials.gov Identifier: NCT01247272
• Other Study ID Numbers: R01-140
• First Posted: November 24, 2010
• Results First Posted: February 21, 2011
• Last Update Posted: February 21, 2011
• Last Verified: January 2011

Keywords provided by Teva Pharmaceuticals USA:

Bioequivalence; Healthy Subjects

Additional relevant MeSH terms:

Fluoxetine; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors