90 mg Fluoxetine Hydrochloride Capsules Under Fasting Con... | NCT01247272

NCT01247272

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reference Listed Drug	Active Comparator	90 mg PROZAC WEEKLY® Capsules (Eli Lilly)	Drug: PROZAC WEEKLY®
Investigational Test Product	Experimental	90 mg Fluoxetine Hydrochloride Capsules (Teva)	Drug: Fluoxetine Hydrochloride

Name	Type	Description	Arm Group Labels	Other Names
Fluoxetine Hydrochloride	Drug	90 mg Capsules	Investigational Test Product

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Cmax of Norfluoxetine.	Informational comparison of Cmax values for the metabolite Norfluoxetine.	Blood samples collected over a 25 day period.
AUC0-t of Norfluoxetine.	Informational comparison of AUC0-t values for the metabolite Norfluoxetine.

Eligibility Module

Eligibility 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/Locations Module

Name	Affiliation	Role
James D Carlson, Pharm.D.	PRACS Institute, Ltd.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
PRACS Institute, Ltd.		Fargo	North Dakota	58102	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
FG000	Fluoxetine Hydrochloride (Test) First	90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
FG001	Prozac® Weekly (Reference) First	90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.

Periods

Title

Milestones

Reasons Not Completed

First Intervention

Type	Comment	Milestone Data
STARTED		FG00013 subjects FG00113 subjects
COMPLETED		FG00013 subjects FG00113 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Washout of 28 Days

Type	Comment	Milestone Data
STARTED		FG00013 subjects FG00113 subjects
COMPLETED		FG00013 subjects FG001

Second Intervention

Type	Comment	Milestone Data
STARTED		FG00013 subjects FG00113 subjects
COMPLETED		FG00013 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Fluoxetine Hydrochloride (Test) First	90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
BG001	Prozac® Weekly (Reference) First

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Cmax of Fluoxetine.

Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).

All participants that completed the study had their samples analyzed.

Posted

Mean

Standard Deviation

ng/mL

Blood samples collected over a 25 day period.

ID	Title	Description
OG000	Fluoxetine Hydrochloride (Test) First	90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
OG001	Prozac® Weekly (Reference) First	90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fluoxetine Hydrochloride (Test) First	90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Headache	General disorders	MedDRA (Unspecified)	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Associate Director, Biopharmaceutics	Teva Pharmaceuticals, USA	1-866-384-5525		clinicaltrialqueries@tevausa.com

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

ID	Term
D005473	Fluoxetine

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals

Masking Info

90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.

EG0006 events5 affected26 at risk

EG0015 events5 affected26 at risk