NCT00200759

Brief Summary

The purpose of this study is to evaluate the potential of cranberry juice to interact with conventional drugs. This study will also determine the the amount of cranberry flavonoids that appear in the blood and in the urine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 25, 2018

Status Verified

November 1, 2009

Enrollment Period

3.2 years

First QC Date

September 12, 2005

Last Update Submit

May 23, 2018

Conditions

HealthyDrug Interactions

Keywords

Vaccinium macrocarponAntioxidantsDrug Interactions

Interventions

Cranberry juice and capsulesDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females must have a negative urine pregnancy test prior to enrollment and must be committed to using barrier methods of birth control throughout the study.

You may not qualify if:

  • Clinically significant diseases or abnormal laboratory values as assessed during the screening medical history, physical exam, and laboratory evaluations.
  • Use of any concomitant medication including herbal medications or a history of hypersensitivity to the medications used in the study
  • History of sensitivity to CB juice or products
  • Poor metabolizers of CYP2D6
  • Active smoking or use of caffeine-containing beverages for 2 weeks prior to and during the study
  • Inability to conform with dietary restrictions required for the study
  • Drug or alcohol abuse (more than 3 drinks/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Capsules

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Jennifer L Donovan, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 25, 2018

Record last verified: 2009-11

Locations

US(1)