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Bioequivalence Between 180 mg and 60 mg ALXN2050 Tablets and Food Effect on ALXN2050 Pharmacokinetics

NCT05578846 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-02-14

No results posted yet for this study

Summary

This study will assess the Bioequivalence between 180 mg and 60 mg ALXN2050 Tablets and the Effect of Food on ALXN2050 Pharmacokinetics.

Conditions

  • Healthy Adult Participants

Interventions

DRUG

Treatment A

Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions.

DRUG

Treatment B

Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions.

DRUG

Treatment C

Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2023-01-05
Completion
2023-01-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05578846 on ClinicalTrials.gov