MedTrace Logo

Oral Bioavailability of a New Formulation of Pterostilbene Cocrystal in Comparison With Its Free Form (BIOPTERO2)

NCT06289140 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-06-06

No results posted yet for this study

Summary

The goal of this interventional study is to to evaluate the oral bioavailability of the crystallized form of pterostilbene (ccPT) compared to its commercial free base form (pterostilbene (PT) in healthy volunteers. The main question it aims to answer are:

• Do the crystallized forms of pterostilbene (ccPT) using two different encapsulation methods exhibit greater bioavailability than its commercial free base form (PT)?

Participants will attend to four visits: a preselection visit (V0), a visit for the first postprandial study (V1), a visit for the second postprandial study (V2) after one-week washing period and a visit for the third postprandial study (V3) after another one week washing period.

Researchers will analyze the three postprandial assays to determine which type of ccPT encapsulation provides the highest bioavailability compared to the commercial free base form (PT).

Conditions

  • Biological Availability

Interventions

DIETARY_SUPPLEMENT

Pterostilbene cocrystal (ccPT) - Gelatin capsule

Participants will intake one gelatin capsule with 75 mg of Pterostilbene cocrystal (ccPT).

DIETARY_SUPPLEMENT

Pterostilbene free form (PT)

Participants will intake one capsule with 50 mg of Pterostilbene free form (PT)

DIETARY_SUPPLEMENT

Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule

Participants will intake one gastro-resistant capsule with 75 mg of Pterostilbene cocrystal (ccPT).

Sponsors & Collaborators

  • Circe, S.L.

    collaborator UNKNOWN

  • Fundació Eurecat

    lead OTHER

Principal Investigators

  • Antoni Caimari, PhD · Fundació Eurecat

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2024-05-07
Completion
2024-05-07

Countries

  • Spain

Study Locations

More Related Trials

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 NCT06289140 on ClinicalTrials.gov