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Cephalexin · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Cephalexin suspension (Optocef, BAYO5448 ) | DRUG | Single dose of 500 mg / 10 mL |
| Cephalexin suspension (Keflex) | DRUG | Single dose of 500 mg / 20 mL |
| Cephalexin capsules (Optocef, BAYO5448 ) | DRUG | Single dose of 500 mg (One 500 mg capsule) |
| Cephalexin capsules (Keflex) | DRUG | Single dose of 500 mg (Two 250 mg capsules) |
| Cephalexin suspension (Optocef, BAYO5448) | DRUG | Single dose of 500 mg / 10 mL |
Inclusion Criteria: * Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis Exclusion Criteria: * History of illnesses or any organic abnormalities that could affect the results of...
Cephalexin is a small molecule anti-infective agent developed by Bayer AG (ticker BAYRY). It is studied in capsule and suspension formulations for anti-infective use. The clinical program registered for Cephalexin consists of Phase 1 bioequivalence studies conducted in Mexico.
Cephalexin is developed by Bayer AG, which trades under the ticker BAYRY. Bayer sponsored the registered Phase 1 bioequivalence studies of the capsule and suspension formulations of Cephalexin conducted in Mexico.
Cephalexin is in Phase 1 development. Three Phase 1 trials have been registered, all of them completed, with no active trials currently listed. The studies were randomized, active controlled, and enrolled a total of 78 participants.
Three completed Phase 1 trials are registered for Cephalexin: NCT01105208, a crossover bioequivalence study of two Cephalexin suspension brands; NCT01073553, a crossover bioequivalence study of two Cephalexin capsule brands; and NCT01073540, another crossover bioequivalence study of two Cephalexin suspension brands. Each enrolled 26 healthy adult volunteers in Mexico.
Yes. Cephalexin is also known as Optocef and BAYO5448. These alternative names apply to both the capsule and suspension formulations of Cephalexin, so searches for Optocef or BAYO5448 refer to the same Bayer AG compound.
Cephalexin is being studied as an anti-infective agent. Its registered clinical program covers capsule and suspension formulations tested for bioequivalence in healthy adult volunteers, rather than in patients with a specific infection. The trials were conducted in Mexico under Bayer AG sponsorship.