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Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions

Sponsor
Par Pharmaceutical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00653393
Collaborator
SFBC Ft. Myers, Inc (Industry)
39
Enrollment
1
Location
2
Arms
2
Duration (Months)
19.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the single-dose Bioavailability of Tranylcypromine and Parnate

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
To Compare Bioavailability of Kali Tranylcypromine 10mg Tablets to That of Parnate 10 mg Tablets Under Fasting Conditions.
Study Start Date :
Oct 1, 2004
Actual Primary Completion Date :
Nov 1, 2004
Actual Study Completion Date :
Dec 1, 2004

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate and Extend of Absorption [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SFBC Ft. Myers, Inc Ft. Myers Florida United States 33901

    Sponsors and Collaborators

    • Par Pharmaceutical, Inc.
    • SFBC Ft. Myers, Inc

    Investigators

    • Principal Investigator: Antonio Pizzaro, SFBC Ft. Myers, Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00653393
    Other Study ID Numbers:
    • 04-0413-001
    First Posted:
    Apr 4, 2008
    Last Update Posted:
    Apr 4, 2008
    Last Verified:
    Apr 1, 2008
    Keywords provided by , ,
    bioequivalence, single- dose, fasting
    Additional relevant MeSH terms:
    Tranylcypromine

    Study Results

    No Results Posted as of Apr 4, 2008