Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Clavamox · 2 trials · 1 indication
Maximum concentration in plasma among observed concentrations at pre-specified time points
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
Maximum concentration in plasma among observed concentrations at pre-specified time points
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
| Arm | Type | Description |
|---|---|---|
| Clavamox,Coated Tablets, 875 mg + 125 mg | EXPERIMENTAL | Clavamox, Film-coated Tablets, 875 mg + 125 mg, is the test product. 14 of 28 subjects in each of two cohorts (total number of enrolled volunteers - 56) were given a single tablet (containing 875 mg mg of amoxicillin and 125 mg of clavulanic acid) in period 1 and period 2 of the clinical part of the study. |
| Augmentin®, Coated Tablets, 875 mg + 125 mg | ACTIVE_COMPARATOR | Augmentin®, Film-coated Tablets, 875 mg + 125 mg, is the reference product. 14 of 28 subjects in each of two cohorts (total number of enrolled volunteers - 56) were given a single tablet (containing 875 mg mg of amoxicillin and 125 mg of clavulanic acid) in period 1 and period 2 of the clinical part of the study. |
| Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml | EXPERIMENTAL | Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml is the test product. 14 of 28 subjects in each of two cohorts (total number of enrolled volunteers - 56) will be given single oral dose (5 ml containing 400 mg of amoxicillin and 57 mg of clavulanic acid) in period 1 and period 2 of the clinical part of the study. |
| Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml | ACTIVE_COMPARATOR | Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml is the reference product. 14 of 28 subjects in each of two cohorts (total number of enrolled volunteers - 56) will be given single oral dose (5 ml containing 400 mg of amoxicillin and 57 mg of clavulanic acid) in period 1 and period 2 of the clinical part of the study. |
| Name | Type | Description |
|---|---|---|
| Clavamox | DRUG | Clavamox, Film-coated Tablets, 875 mg + 125 mg, manufactured by Pharmtechnology LLC, Belarus |
| Augmentin® | DRUG | Augmentin®, Film-coated Tablets, 875 mg + 125 mg, marketed by GlaxoSmithKline Trading CJSC, Russia |
Inclusion Criteria: * Caucasian men or women aged between 18 to 45 years * Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments and imaging studies. * Body mass index 18.5-29.9 kg/m² with body m...
Clavamox is an investigational small molecule being studied for bioequivalence. It is a powder for oral suspension and film-coated tablets being compared to Augmentin in healthy volunteers under fasting conditions. The drug is in Phase 1 clinical development and is not FDA approved.
Clavamox is being developed by Ligand Pharmaceuticals Incorporated, which trades under the ticker LGND. The company is conducting bioequivalence studies of Clavamox against Augmentin in healthy volunteers in Russia.
Clavamox is in Phase 1 clinical development. Two Phase 1 bioequivalence studies have been completed, with a total of 112 participants enrolled. The drug is investigational and has not been approved by the FDA.
Clavamox has two completed Phase 1 trials: NCT03616301, a bioequivalence study of the oral suspension 400 mg + 57 mg per 5 ml, and NCT03702894, a bioequivalence study of film-coated tablets 875 mg + 125 mg. Both compared Clavamox to Augmentin in healthy volunteers under fasting conditions in Russia.
Clavamox is being studied as a potential generic equivalent to Augmentin. The bioequivalence trials compare Clavamox formulations to Augmentin products from GlaxoSmithKline. However, Clavamox is a distinct product being developed by Ligand Pharmaceuticals and is not yet approved.