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Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)

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NCT00925535

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

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

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease.

- History of regular alcohol consumption exceeding 7 drinks/week for women and 14
drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard
liquor).

- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
cigarettes per day.

- Hypersensitivity/allergic reactions to any component of the study drugs.

NCT00925535
Pfizer
Completed
Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)

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Pfizer Clinical Trials Contact Center

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[email protected]

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Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Rifabutin And Lersivirine (UK-453,061) In Healthy Subjects
Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: Lersivirine
    1000 mg once daily for 10 days
  • Drug: Rifabutin
    300 mg once daily for 10 days
  • Active Comparator: Treatment A
    Lersivirine
    Intervention: Drug: Lersivirine
  • Active Comparator: Treatment B
    Rifabutin
    Intervention: Drug: Rifabutin
  • Experimental: Treatment C
    Lersivirine and Rifabutin
    Interventions:
    • Drug: Lersivirine
    • Drug: Rifabutin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • History of regular alcohol consumption exceeding 7 drinks/week for women and 14 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • Hypersensitivity/allergic reactions to any component of the study drugs.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
United States
 
NCT00925535
A5271043
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2010

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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