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Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837

NCT00878618 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2009-06-03

No results posted yet for this study

Summary

The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions.

Conditions

  • Healthy

Interventions

DRUG

AZD0837

Extended-release tablets, test formulation. 2 tablets given in the morning for 6 days

DRUG

AZD0837

Extended-release tablets, reference formulation. 2 tablets given in the morning for 6 days

Sponsors & Collaborators

Principal Investigators

  • Elisabeth Edén Eden · Quintiles AB, Uppsala, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Completion
2009-05-31

Countries

  • Sweden

Study Locations

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Entities

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 NCT00878618 on ClinicalTrials.gov