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A Bioavailability Study Comparing Modified-release Capsules and Immediate Release Capsules in Fed and Fasting Conditions

NCT01092299 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2010-08-27

No results posted yet for this study

Summary

Part 1: The purpose of this study is to determine the pharmacokinetic profile of 4 different Extended/modified-release formulations and one immediate release formulation of AZD1446. In addition the food effect on AZD1446 pharmacokinetics will be investigated.

Part 2: To asses the safety and tolerability of the selected formulation(s) from part 1 in elderly healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

AZD1446

ER Fast, 90mg, p.o. capsule

DRUG

AZD1446

ER Moderate, 90mg, p.o. capsule

DRUG

AZD1446

ER Slow, 90mg, p.o. capsule

DRUG

AZD1446

MR

DRUG

AZD1446

IR, 90 mg p.o. capsule

DRUG

Placebo

IR

DRUG

Placebo

ER/MR

Sponsors & Collaborators

Principal Investigators

  • Lena Bolin · AstraZeneca R&D

  • Aslak Rautio · Quintiles Hermelinen AB

  • Wolfgang Kühn · Quintiles AB, Phase I Services

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
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 NCT01092299 on ClinicalTrials.gov