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An Interaction Study of Ketoconazole/Verapamil Versus AZD1305

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Ketoconazole (Drug); Verapamil (Drug); AZD1305 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Helen Lunde, MD, Study Director, Affiliation: AstraZeneca R&D Mölndal, Sweden
Dago Mazur, MD, PhD, Principal Investigator, Affiliation: PAREXEL International GmbH, Berlin, Germany


The purpose is to study whether ketoconazole or verapamil have an effect on how AZD1305 is handled by the body, i. e the absorption, distribution, metabolism and excretion, when administered in combination with AZD1305.

Clinical Details

Official title: A Phase I, Single-centre, Randomised, Open, Three-way Crossover Study to Evaluate the Effect of Ketoconazole and Verapamil, Respectively, on the Pharmacokinetics of AZD1305 After Repeated Oral Adm of Ketoconazole and Verapamil and Single Oral Dosing of AZD1305 to Young Healthy Male Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pharmacokinetic variables

Secondary outcome: Adverse events, vital signs, ECG, laboratory variables and physical examination


Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.


Inclusion Criteria:

- A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion Criteria:

- Potassium outside normal reference values

- ECG findings outside normal range

Locations and Contacts

Research Site, Berlin, Germany
Additional Information

Starting date: July 2008
Last updated: December 2, 2010

Page last updated: August 23, 2015

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