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A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers

NCT05690932 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-02-01

No results posted yet for this study

Summary

This is a single-dose, two-part, crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers.

Conditions

  • Formulation Bridging
  • Food Effect

Interventions

DRUG

PBI-200 Tablet

Single dose of PBI-200 tablet

DRUG

PBI-200 Capsule

Single dose of PBI-200 capsule

DRUG

PBI-200 Suspension

Single dose of PBI-200 suspension

Sponsors & Collaborators

  • Pyramid Biosciences

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Pyramid Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-02-24
Primary Completion
2022-05-23
Completion
2022-05-23
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 NCT05690932 on ClinicalTrials.gov