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Also known as Cephalexin 1g tablets
Cephalexin · 3 trials · 1 indication
Pharmacokinetics
Pharmacokinetics
| Arm | Type | Description |
|---|---|---|
| A(reference)/B(test) | EXPERIMENTAL | initial administration of reference and cross-over to test |
| B(test)/A(reference) | EXPERIMENTAL | initial administration of test and cross-over to reference |
| A (reference)/ B (test) | EXPERIMENTAL | initial administration of reference and cross-over to test |
| B (test)/ A (reference) | EXPERIMENTAL | initial administration of test and cross-over to reference |
| Name | Type | Description |
|---|---|---|
| Cephalexin 125 mg/5ml | DRUG | Reference product 20 ml |
| Cephalexin 250mg/5ml | DRUG | Test product 10 ml |
| Cephalexin 1g tablets | DRUG | Reference product |
Inclusion Criteria: Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice. Healthy, between 18 and 50 years. Body Mass Index between 18 and 27.5 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; ...
Cephalexin is studied for infections, including respiratory tract infections. The clinical trials listed for cephalexin enroll healthy adult volunteers in bioequivalence studies rather than patients treated for active infection. Cephalexin is a small molecule anti-infective developed by GSK plc.
GSK plc, which trades under the ticker GSK, is the developer of cephalexin. The company is associated with the cephalexin tablet and suspension programs described in the clinical trial listings for this anti-infective asset.
Cephalexin is in Phase 1 development. All three listed trials are Phase 1 bioequivalence studies, and all three are completed, with no active trials currently listed. The studies together enrolled 82 participants.
Three completed Phase 1 trials cover cephalexin: NCT01767584, a bioequivalence study of cephalexin 1g tablets with 26 participants; NCT01767571, a bioequivalence study of cephalexin suspension 250 with 28 participants; and NCT01767532, a bioequivalence study of cephalexin suspension 125 with 28 participants.
Yes. The cephalexin Phase 1 trials are randomized and controlled, though they are not double blind. They enrolled healthy volunteers aged 18 years and older of all sexes, and none of the trials used biomarker selection.