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Completed

NCT Number: NCT00653393

Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions

To compare the single-dose Bioavailability of Tranylcypromine and Parnate

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SFBC Ft. Myers, Inc

Fort Myers, Florida, 33901, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranylcypromine

Drug

Tablets, 10 mg, single-dose

Other names: Parnate

Parnate

Drug

Tablets, 10 mg, single-dose

Other names: Tranylcypromine

Primary outcomes

  1. Rate and Extend of Absorption

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Par Pharmaceutical, Inc.

Industry

Collaborators

  • SFBC Ft. Myers, Inc

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Apr 4, 2008
Registry last updated
Apr 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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