At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Cephalexindrug
Likely dose
Not stated in 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.
A Randomized, Open-label, Two-period, Two-treatment, Two-sequence, Crossover Study to Evaluate the Bioequivalence of Single Doses of Two Oral Preparations in Capsules With 250 mg of Cephalexin (Keflex® Made in Mexico by Eli Lilly y Compañía de México, S.A. de C.V. vs. Keflex® Made in Italy by Facta Farmaceutici S.p.A. for Eli Lilly y Compañía de México, S.A. de C.V.) in Fasting Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Cephalexin for Healthy Volunteers. Completed, enrolled 28 participants across 1 site.
Detailed Summary
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin in capsules to determine if they are essentially the same. The study has two periods. Participants will receive one preparation of cephalexin in each period. At least 7 hours will pass between the study periods. The study is expected to last about 2 days for each participant, not including screening or follow-up.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesMexico
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedApr 2014
Primary CompletionMay 2014
TodayJul 2026
First PostedApr 25, 2014
Enrollment StartApr 1, 2014
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 12.2 years ago
Interventions
Cephalexindrug
Administered orally.