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 Suspension With 250 mg/5 ml of Cephalexin (Keflex® Liquido Made in Mexico by Eli Lilly y compañía De méxico, s.a. De cv. Vs. Keflex® Liquido Made by Antibioticos do Brasil Ltda 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. 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 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
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
Primary CompletionJul 2015
First PostedJul 2015
TodayJul 2026
First PostedJul 7, 2015
Enrollment StartJul 1, 2015
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 11.0 years ago
Interventions
Cephalexindrug
Administered orally