NCT00905333

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

2 active sites

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, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
Last Updated

December 7, 2010

Status Verified

December 1, 2010

Enrollment Period

1 month

First QC Date

May 19, 2009

Last Update Submit

December 6, 2010

Conditions

Healthy

Keywords

pharmacokineticscandesartanfelodipinetest formulationsAtacand®Splendil®healthy volunteersblood samplesafter meal intake interactionKinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period.

Outcome Measures

Primary Outcomes (1)

  • Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®.

    76 blood samples per subject

Study Arms (1)

Single-arm

OTHER

3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)

Drug: Candesartan (test)Drug: Felodipine (test)Drug: Candesartan CilexetilDrug: Felodipine

Interventions

Candesartan (test)DRUG

16 mg oral tablet, single dose

Single-arm
Felodipine (test)DRUG

5 mg oral extended release tablet, single dose

Single-arm
Candesartan CilexetilDRUG

16 mg oral tablet, single dose

Also known as: Atacand®
Single-arm
FelodipineDRUG

5 mg oral extended release tablet, single dose

Also known as: Splendil®
Single-arm

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers
  • BMI \> or = 19 and \< or = 28 (Dietary Guidelines Advisory Committee, 2005)

You may not qualify if:

  • Not healthy
  • Chronic drug intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Itatiba, São Paulo, Brazil

Location

Research Site

Americana, Brazil

Location

MeSH Terms

Interventions

candesartanFelodipinecandesartan cilexetil

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Eduardo Abib Junior, MD

    Scentryphar Clinical Research

    PRINCIPAL INVESTIGATOR

  • Moises L. P Vanuncci, MD

    Scentryphar Clinical Research

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 20, 2009

Study Start

October 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 7, 2010

Record last verified: 2010-12

Locations

BR(2)