Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions

To Compare Bioavailability of Kali Tranylcypromine 10mg Tablets to That of Parnate 10 mg Tablets Under Fasting Conditions.

To compare the single-dose Bioavailability of Tranylcypromine and Parnate

Study Overview

• Status: Completed
• Conditions: To Determine the Bioavailability of Tranylcypromine
• Intervention / Treatment: Drug: Tranylcypromine; Drug: Parnate

Detailed Description

To compare the relative Bioavailability of Tranylcypromine 10 mg tablets with that of PARNATE 10mg tablets in normal,healthy, men and women under fasting conditions

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Ft. Myers, Florida, United States, 33901
      • SFBC Ft. Myers, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects will be normal, healthy adult men and women who volunteer to participate.
• Is the individual healthy, nonsmoking, normal adult man or woman who volunteers to participate?
• Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, exclusive?
• Is she willing to avoid pregnancy by abstaining from sexual intercourse, or by the use of barrier methods. (diaphragm, condom, foams/jellies, sponge), and IUD, or has she has been surgically sterile or post- menopausal at least six months prior to entering into the study?
• Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
• Has/s/he provided written informed consent?
• A no answer to any of the above questions indicates taht the individual is ineligible for enrollment.

Exclusion Criteria:

• Does the individual have a history of allergy or hypersensitivity to tranylcypromine?
• Does/ s/he have clinically significant laboratory abnormalities that would interface with the conduct or interpretation of the study or jeopardize his/her safety?
• Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interface with the conduct or interpretation of the study or jeopardize his/her safety?
• Is she nursing?
• Does s/he have serious psychological illness?
• Does s/he have significant history ( within the past year) or clinical evidence of alcohol or drug abuse?
• Does s/he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-1 , or hepatitis B or C screen, or a positive pregnancy test?-Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the alst blood sample has been taken?
• Is s/he unable to refrain from the ingestion of smoked meat, cheese (except cream cheese and cottage cheese), wine and beer during periods beginning 48 hours prior to study initiation and ending seven days after the last blood sample has been taken in study period two?
• Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation?
• Is s/he unable to refrain from the use of all concomitant medications during the study?
• Ha s/he donated or lost blood, or participated in a clinical study which involved the with drawl of a large volume of blood (480mL or more), during the six week period preceding study initiation?
• Has s/he donated an investigational drug during the 30 day period preceding study initiation?
• A yes answer to any of the above questions indicates that the individual is ineligible for enrollment.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Subjects received Kali product under fasting conditions	Drug: Tranylcypromine; Tablets, 10 mg, single-dose; Other Names: Parnate
Active Comparator: B; Subjects received Parnate product under fasting conditions	Drug: Parnate; Tablets, 10 mg, single-dose; Other Names: Tranylcypromine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and Extend of Absorption	24 hours

Collaborators and Investigators

• Sponsor: Par Pharmaceutical, Inc.
• Collaborators: SFBC Ft. Myers, Inc
• Investigators: Principal Investigator: Antonio Pizzaro, SFBC Ft. Myers, Inc

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): November 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: April 1, 2008
• First Submitted That Met QC Criteria: April 3, 2008
• First Posted (Estimate): April 4, 2008

Study Record Updates

• Last Update Posted (Estimate): April 4, 2008
• Last Update Submitted That Met QC Criteria: April 3, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: bioequivalence, single- dose, fasting
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Anti-Anxiety Agents; Monoamine Oxidase Inhibitors; Tranylcypromine
• Other Study ID Numbers: 04-0413-001