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Study Evaluating a Combined Administration of Lecozotan SR and Citalopram in Young Healthy Subjects

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Manchester, , United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Signed and dated IRB/IEC-approved informed consent form before any study-specific
screening procedures are performed.

- Men or women aged 18 to 50 years, inclusive, at screening.

- Women of nonchildbearing potential, defined as being surgically sterile or
postmenopausal for > 1 year, may be included. For women below 50 years of age, at
least two years of retrospective amenorrhea and FSH>38 and estrogen

- Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than
or equal to 50 kg. BMI is calculated by taking the subject's weight, in kilograms,
divided by the square of the subject's average height, in meters, at screening: BMI =
weight (kg)/(height [m])2

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Presence or history of any disorder that may prevent the successful completion of the
study.

- Any clinically important deviation from normal limits in physical examination, vital
signs, 12-lead ECGs, or clinical laboratory test results.

- Hypersensitivity to citalopram or any of the inactive ingredients in citalopram.

NCT00538889
Pfizer
Completed
Study Evaluating a Combined Administration of Lecozotan SR and Citalopram in Young Healthy Subjects

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Study Evaluating a Combined Administration of Lecozotan SR and Citalopram in Young Healthy Subjects
Combined Administration of Lecozotan SR and Citalopram: a Double Blind, Multiple Dose Study in Young Healthy Subjects
To assess the safety and tolerability of lecozotan SR and citalopram when coadministred to healthy subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Healthy
  • Drug: Lecozotan SR
  • Drug: Citalopram
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2007
Not Provided

Inclusion Criteria:

  • Signed and dated IRB/IEC-approved informed consent form before any study-specific screening procedures are performed.
  • Men or women aged 18 to 50 years, inclusive, at screening.
  • Women of nonchildbearing potential, defined as being surgically sterile or postmenopausal for > 1 year, may be included. For women below 50 years of age, at least two years of retrospective amenorrhea and FSH>38 and estrogen <20 are required.
  • Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening: BMI = weight (kg)/(height [m])2

Exclusion Criteria:

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results.
  • Hypersensitivity to citalopram or any of the inactive ingredients in citalopram.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00538889
3098B1-134
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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