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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: AZD1446
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01092299
2009-017702-36 (EudraCT Number)
D1950C00008

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Body mass index (BMI) between 19 and 30 kg/m2
  • Clinically normal findings on physical examination

Exclusion criteria

  • History of any clinically significant disease or disorder
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • History or present symptoms or signs of severe allergy/hypersensitivity reactions including severe food allergy, as judged by the investigator

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

62 participants in 6 patient groups, including a placebo group

Cohort 1 (2 arms)
Experimental group
Description:
Period 1: randomized to either fasting IR or ER1. Period 2: Cross-over to either IR or ER1. Period 3: ER1 in fed conditions.
Treatment:
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Cohort 2 (2 arms)
Experimental group
Description:
Period 1: randomized to either fasting IR or ER2. Period 2: Cross-over to either IR or ER2. Period 3: ER2 in fed conditions.
Treatment:
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Cohort 3( 2 arms)
Experimental group
Description:
Period 1: randomized to either fasting IR or ER3. Period 2: Cross-over to either IR or ER3. Period 3: ER3 in fed conditions.
Treatment:
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Cohort 4 (2 arms)
Experimental group
Description:
Period 1: randomized to either fasting IR or MR4. Period 2: Cross-over to either IR or MR4. Period 3: MR4 in fed conditions.
Treatment:
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Part 2: Extended/Modified release
Experimental group
Description:
Extended/Modified release capsule to be determined
Treatment:
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Drug: AZD1446
Part 2: Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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