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Evaluate Different Extended-release (ER) Tablets/Capsules of AZD1305

A Phase I, Two-part, Randomised, Open, Single-centre, Crossover Study to Evaluate Different Extended-release Formulations of AZD1305 When Given as Single Oral Doses to Healthy Male Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00689403
Acronym
2007-005765-38
Enrollment
50
Registered
2008-06-03
Start date
2008-02-29
Completion date
2008-07-31
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

Healthy

Keywords

AZD1305, pharmacokinetics, Properties of different ER formulations

Brief summary

To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.

Interventions

DRUGAZD1305

Extended release capsules, oral single doses

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy male between the age of 20 - 45 * Non-smoking

Exclusion criteria

* Potassium outside normal reference values * ECG findings outside normal range

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic variablesDuring all dosing visits

Secondary

MeasureTime frame
Adverse events, ECG, safety laboratory, vital signs, physical examinationDuring the study

Countries

United Kingdom

Outcome results

None listed

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