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A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral S

2016-11-16 12:08:21 | BioPortfolio

Summary

This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center, crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of rosuvastatin, and to assess the relative bioavailability of AZD5718 oral suspension vs AZD5718 immediate release (IR) Tablet Formulation and the Food Effect of AZD5718 in Healthy Volunteers. The study will be performed at a single study center.

Description

The study will comprise:

- A Screening period of maximum 28 days;

- Five treatment periods during which subjects will be resident from the morning on the day before dosing with the IMP (Day -1) until at least 48 hours after dosing; discharge will be on the morning of Day 3, and

- A Follow-up Visit within 7 to 10 days after the last administration of the IMPs.

- There will be a minimum of a 7 days washout between each treatment period.

Each subject will receive 5 treatments. The following treatments will be given:

- Treatment A: 10 mg rosuvastatin tablet alone (fasting state)

- Treatment B: 10 mg rosuvastatin tablet + 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)

- Treatment C: 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)

- Treatment D: 200 mg of AZD5718 oral suspension 50 mg/mL (fasting state)

- Treatment E: 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fed state)

Each subject will be involved in the study for approximately 8 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

High Risk Coronary Artery Disease

Intervention

AZD5718 IR tablet, AZD5718 oral suspension, Rosuvastatin tablet

Location

Research Site
London
United Kingdom

Status

Not yet recruiting

Source

AstraZeneca

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-16T12:08:21-0500

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