CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 160 enrolled
Drug / intervention
Clopidogrel +4 moredrug
Likely dose
Clopidogrel 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00942175
NCT00942175Phase 1Completed

A Phase 1, Randomized, Open-Label, 2-Period, Crossover Design Study to Assess the Effects of Multiple Oral Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Steady-State Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Subjects

Takeda·interventional·Posted Jul 20, 2009·Updated Feb 3, 2012

In Brief

A Phase 1 clinical trial evaluating Clopidogrel, Clopidogrel and Lansoprazole, and 3 other interventions for Healthy. Completed, enrolled 160 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the potential effect and safety of multiple oral doses of dexlansoprazole, lansoprazole, omeprazole or esomeprazole, once daily (QD), on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel, and to assess the safety of multiple doses of clopidogrel in healthy participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2009
Enrollment StartDec 1, 2009
Primary CompletionJun 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.9 years ago

Interventions

Clopidogreldrug

Clopidogrel 75 mg, tablets, orally, once daily days 1-9.

Clopidogrel and Lansoprazoledrug

Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily days 1-9.

Clopidogrel and Dexlansoprazoledrug

Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily days 1-9.

Clopidogrel and Omeprazoledrug

Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily days 1-9.

Clopidogrel and Esomeprazoledrug

Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily days 1-9.