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CompletedNCT00653393Updated Apr 4, 2008

Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions

A Phase 1 interventional study of Tranylcypromine and Parnate in To Determine the Bioavailability of Tranylcypromine, sponsored by Par Pharmaceutical, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-04.

Sponsored by Par Pharmaceutical, Inc. (part of Par Health) · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To compare the single-dose Bioavailability of Tranylcypromine and Parnate

Read the 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

02

Conditions studied

  • To Determine the Bioavailability of Tranylcypromine

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Keywords

  • bioequivalence, single- dose, fasting
03

In context

Fasting

86 studies on the registry are indexed under Fasting; 38 are open to participants now.

This study's enrollment of 39 is below the median of 60 across 66 interventional studies indexed under Fasting.

Browse Fasting studies →

Lead sponsor

Par Pharmaceutical, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.

First submitted before Par Pharmaceutical, Inc. became part of Par Health.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    A

    Subjects received Kali product under fasting conditions

    Drug: Tranylcypromine

  • Active comparator
    B

    Subjects received Parnate product under fasting conditions

    Drug: Parnate

Interventions

  • Tablets, 10 mg, single-dose

    Also known as: Parnate

  • Tablets, 10 mg, single-dose

    Also known as: Tranylcypromine

06

What researchers measure

Primary outcomes

  1. Rate and Extend of Absorption

    Time frame: 24 hours

07

Study locations

1 site
  • SFBC Ft. Myers, Inc
    Fort Myers, Florida 33901, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00653393
Collaborators
SFBC Ft. Myers, Inc
First posted
Apr 4, 2008
Start date
Oct 2004
Primary completion
Nov 2004
Completion
Dec 2004
Last update
Apr 4, 2008

Study contacts

Antonio Pizzaro
principal investigator · SFBC Ft. Myers, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tranylcypromine

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