Trials / Completed
CompletedNCT01767584
Bioequivalence Study of Cephalexin Tablets 1g
Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations Containing 1 g of Cephalexin (GlaxoSmithKline México, S.A. de C.V. vs. Keflex® 1g, Eli Lilly y Compañía de México, S.A. de C.V.) in Fasting Healthy Volunteers.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study was to confirm if two formulations of cephalexin tablets are bioequivalent. Test product was Ceporex® (1 g Cephalexin; GlaxoSmithKline) and reference product Keflex® (1 g Cephalexin; Eli Lilly). The single dosage was one tablet. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 26 healthy volunteers, both genders, adults between 18-40 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cephalexin 1g tablets | Reference product |
| DRUG | Cephalexin 1g tablets | Test product |
Timeline
- Start date
- 2009-04-06
- Primary completion
- 2009-04-14
- Completion
- 2009-04-14
- First posted
- 2013-01-14
- Last updated
- 2017-07-07
Source: ClinicalTrials.gov record NCT01767584. Inclusion in this directory is not an endorsement.