Study to Compare Different Formulations of AZD3355

A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae After Dosing in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00688402

Enrollment

Registered

2008-06-03

Start date

2008-04-30

Completion date

2008-06-30

Last updated

2010-12-03

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

Conditions

Gastroesophageal Reflux Disease

Keywords

Reflux Inhibitor, GERD, formulations

Brief summary

The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.

Interventions

DRUGAZD3355

Single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of written informed consent * Female subjects with no childbearing potentials or using highly efficient contraceptive methods * Clinically normal physical findings

Exclusion criteria

* Clinically significant illness within 2 weeks prior to the first dose of investigational product * History of clinically significant disease * Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Design outcomes

Primary

Measure	Time frame
Specific AE questions	During 0-4 hours post dose

Secondary

Measure	Time frame
PK variables	Frequent sampling up to 36 hours post dose
Safety variables (other adverse events, blood pressure, pulse, safety lab)	During the whole treatment period

Countries

Sweden

Outcome results

None listed

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