AZD 2066 Single Dose Formulation and Food Effect Study in Healthy Volunteers

A Phase 1, Single-center, Randomized, Open-label, Two-way Crossover, Formulation and Food Effect Study in Healthy Volunteers, to Assess the Pharmacokinetics of AZD 2066 After Single Doses of a New Oral Solid Formulation and an Oral Solution

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00690404

Enrollment

Registered

2008-06-04

Start date

2008-04-30

Completion date

2008-06-30

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

formulation, pharmacokinetic, crossover formulation, food effect, oral solution, healthy volunteers

Brief summary

A open label two way crossover formulation and food effect study in healthy volunteers to assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an oral solution

Interventions

DRUGAZD2066

single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Clinical normal physical findings, including BP, pulse rate \>45 bpm, ECG and laboratory assessments * Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg

Exclusion criteria

* History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator. * History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.

Design outcomes

Primary

Measure	Time frame
AZ2066 pharmacokinetics	several samples within 72 hrs

Secondary

Measure	Time frame
Effect of food on AZD2066 pharmacokinetics	several samples over 72 hrs

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026