Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03702894 | Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions | PHASE1 | COMPLETED | 56 | — | — | Sep 21, 2018 | Oct 8, 2018 | May 14, 2019 | 1 | Russia |
| NCT03616301 | Bioequivalence Study of Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (Pharmtechnology LLC, Belarus), and Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions | PHASE1 | COMPLETED | 56 | — | — | Jul 28, 2018 | Aug 13, 2018 | Oct 15, 2018 | 1 | Russia |
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...