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A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine)

NCT00988624 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-01-12

No results posted yet for this study

Summary

This study will evaluate four different modified release formulation to estimate the amount of dimebon available to the body relative to the current dimebon formulation that is given three times a day. The results of this study will help inform and guide further formulation development efforts with the ultimate goal of reducing dose frequency to once-a-day or twice-a-day.

Conditions

Interventions

DRUG

Dimebon IR Tablet

Pharmacokinetics of a single oral dose of 10 mg dimebon immediate release tablet will be assessed on Day 1 - 3.

DRUG

Dimebon MR1

Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR1, will be assessed on Day 1 - 3.

DRUG

Dimebon MR2

Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR2, will be assessed on Day 1 - 3.

DRUG

Dimebon MR3

Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR3, will be assessed on Day 1 - 3.

DRUG

Dimebon MR4

Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR4, will be assessed on Day 1 - 3.

Sponsors & Collaborators

  • Medivation, Inc.

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988624 on ClinicalTrials.gov