Bioavailability Of Lersivirine Single 750 Mg Tablet Versus 3 X 250 Mg Tablets

Overview

This is a randomized study to assess whether the pharmacokinetics of a new single 750 mg tablet is similar to 3 x 250 mg tablets (750 mg total).

Full Title of Study: “Open-Label, Randomized, 2-Way Crossover Study To Estimate The Pharmacokinetics And Bioavailability Of Lersivirine (UK 453,061) Administered As A Single 750 Mg Tablet And 3 X 250 Mg Tablets In Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2010

Interventions

  • Drug: Lersivirine
    • Oral Lersivirine 750 mg (1 x 750 mg) single dose
  • Drug: Lersivirine
    • Oral Lersivirine 750 mg (3 x 250 mg) single dose

Arms, Groups and Cohorts

  • Experimental: Lersivirine (new formulation)
  • Active Comparator: Lersivirine (old formulation)

Clinical Trial Outcome Measures

Primary Measures

  • To estimate the bioavailability of 1 x 750 mg lersivirine tablet compared to 3 x 250 mg lersivirine tablets.
    • Time Frame: 7 days

Secondary Measures

  • To investigate the safety and tolerability of both single oral 750 mg (3 x 250 mg and 1 x 750 mg) dose of lersivirine.
    • Time Frame: 7 days

Participating in This Clinical Trial

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. – Total body weight >50 kg (110 lbs). Exclusion Criteria:

  • Treatment with an investigational drug within 30 days or 5 half-lives or local regulation (whichever is longer) preceding the first dose of study medication. – Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. – History of regular alcohol consumption exceeding 14 drinks/week for women and 21 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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