BioequivalencePhase 1NCT03616301
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
A Phase 1 study testing Clavamox and Augmentin® in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Russia.
Trial summary
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject will be randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Clavamox and Augmentin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteRussia
- Study dates
- 28 Jul 2018to 13 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 mass >45 kg and ≤100 kg
- non-breastfeeding women
- non-pregnant women
- if subject is a female and is of child bearing potential, she should be practicing an acceptable non-hormonal method of birth control for the duration of the study(at least 14 days before the start of the study, throughout the study and 14 days after the completion of the study), such as a combination of male condom and diaphragm with spermicide
- if subject is a male and and has a female partner of child bearing potential, he should be practicing an acceptable method of birth control for the duration of the study(at least 14 days before the start of the study, throughout the study and 14 days after the completion of the study), such as a combination of male condom and spermicide (double barrier method).
- subjects are able to understand the requirements of the study, to sign a written informed consent, and also to accept all the restrictions imposed during the course of the study, and to agree to return for the required investigations.
Who cannot join
- Subjects with a known history of allergic disorders.
- Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients of the test and the reference product.
- Subjects with a known history of drug intolerance.
- History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to any of beta-lactam agents (e.g. a cephalosporin, carbapenem or monobactam).
- History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.
- Dehydration due to diarrhea, vomiting or other reasons within 24 hours prior to start of the first period of the study.
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- Subjects with history of psychiatric disorders.
- History of convulsions, epilepsy and any other neurological disorders.
- Dietary sodium restriction within two weeks prior to start of the study or adherence to special types of diets (vegetarian, vegan, with salt restriction) and lifestyle (work at night, extreme physical activity).
- Use of gestagen-containing injectable hormonal contraceptives, implants, intrauterine hormonal therapeutic systems within 6 months prior to start of the study.
- Female subjects of child bearing potential having unprotected intercourse with an unsterilized sexual partner within 30 days prior to start of the study.
- Consumption of xanthine-containing foods and drinks (tea, coffee, coca-cola, chocolate) within 72 hours prior to start of the first period of the study.
- Consumption of citrus fruits (including grapefruit and grapefruit juice) and cranberries (including cranberry juice and other cranberry drinks) within 14 days prior to start of the study.
- Cardiovascular, respiratory, gastrointestinal diseases, neuroendocrine disorders, renal and/or hepatic impairment, blood system disorders.
- Other conditions which, according to the researcher's judgment, may affect absorption, distribution, biotransformation and elimination of any formulation or increase risks of deterioration of volunteer's condition.
- Surgical interventions on the gastrointestinal tract with the exception of appendectomy.
- Acute infectious diseases less than 4 weeks prior to the start of the study.
- ECG abnormalities.
- Sitting systolic blood pressure < 100 mm Hg or > 130 mm Hg and/or sitting diastolic blood pressure < 70 mm Hg or > 90 mm Hg.
- Heart rate <60 or >80 beats per minute at screening check-in.
- Use of liver enzyme inducers and inhibitors, in particular isoenzyme CYP3A4 (inducers: omeprazole, cimetidine, products containing the extract of Hypericum perforatum, barbiturates, carbamazepine, phenytoin, glucocorticoids; inhibitors: antiviral drugs, clarithromycin, ciprofloxacin, gestodene) within 30 days prior to the start of the study.
- Use of any systemic drugs within 14 days prior to the start of the study.
- Use of OTC drugs, including herbs and nutritional supplements within 7 days prior to the Dosing Date. (including vitamins and natural food additives, phyto supplements,herbal preparations such as, cat's claw, angelica officinalis, oenothera, feverfew, garlic, ginger, ginkgo, red clover, horse chestnut, green tea, ginseng).
- Donation of plasma or blood (450 ml or more) within 2 months prior to the start of the study.
- Intake of more than 10 units alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml dry wine or 50 ml of spirits) or history alcoholism, drug addiction, drug abuse.
- Smoking more than 10 cigarettes per day.
- Participation in other clinical trials of medicines within 3 months prior to the start of the study.
- Positive test for syphilis, hepatitis B, hepatitis C or HIV.
- Positive pregnancy test (for female subjects with child bearing potential).
- Breast-feeding.
- Positive test for alcohol.
- Positive urinary screen test for drugs of abuse.
- Oral contraceptives should be withdrawn 2 months prior to the start of the study.
- Subjects who refuse to comply with the study protocol and/or not credible therein and who are, at the discretion of the Principal Investigator, unable to understand and assess the information about the study, expected risks and possible discomfort in the process of signing written informed consent.
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Autonomous Healthcare Facility of the Yaroslavl Region "Clinical Hospital No. 2"
Yaroslavl, Yaroslavl Oblast, 150010
About this study
Official title: Open-label, Randomized, Crossover, Two-period, Two-sequence, Single-center, Comparative 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
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject will be randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.
Read the detailed description
The objective of this study is to establish if two formulations of amoxicillin + clavulanic acid combination are bioequivalent. Also monitoring, registration and evaluation of adverse events will be performed. The test formulation is Clavamox, powder for oral suspension, 400 mg + 57 mg / 5 ml (Pharmtechnology LLC, Belarus). The reference formulation is Augmentin®, powder for oral suspension, 400 mg + 57 mg / 5 ml (GlaxoSmithKline Trading CJSC, Russia).
56 healthy adult volunteers of both genders, with age ranging from 18 to 45 years old, will be divided into two cohorts with equal number of subjects (28). Each subject in a cohort will receive single dose (5 ml containing 400 mg of amoxicillin and 57 mg of clavulanic acid) of the test or the reference formulation with 200 ml of water after an overnight fast of at least 10 hours, according to the pre-defined randomization list, i. e. 14 subjects in each cohort will receive the test product and 14 subjects in each cohort will receive the reference product. Subjects will fast 4 hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period.
In each period blood samples will be collected before dosing and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing (total number: 19). The washout period is 7 days.
A validated HPLC/MS/MS method will be used to determine plasma concentrations of two analytes (amoxicillin and clavulanic acid).
ANOVA will be performed on log-transformed pharmacokinetic parameters Cmax, AUC0-t and 90% confidence interval will be constructed for the ratio of geometric least square means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for each analyte, both falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t.
- Conditions
- Bioequivalence
- Being tested
- Clavamox, Augmentin®
- Keywords
- bioequivalence, amoxicillin, clavulanic acid, Augmentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClavamoxDrug
Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml, manufactured by Pharmtechnology LLC, Belarus
Augmentin®Drug
Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml, marketed by CJSC GlaxoSmithKline Trading, Russia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Clavamox |
| 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. Receives: Drug: Augmentin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of amoxicillin for the test and the reference products
Maximum concentration in plasma among observed concentrations at pre-specified time points
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
AUC0-t of amoxicillin for the test and the reference products
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Cmax of clavulanic acid for the test and the reference products
Maximum concentration in plasma among observed concentrations at pre-specified time points
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
AUC0-t of clavulanic acid for the test and the reference products
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Secondary outcomes (11)
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
An AE is defined as any untoward medical occurrence in a subject administered an investigational product and which does not necessarily have a causal relationship with the treatment. The data from participants who had taken at least one investigational product was analyzed.
Measured: 17 days
AUC0-∞ of amoxicillin for the test and the reference products
Area under the plasma concentration versus time curve from time 0 to to infinite time
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
AUC0-∞ of clavulanic acid for the test and the reference products
Area under the plasma concentration versus time curve from time 0 to to infinite time
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Tmax of amoxicillin for the test and the reference products
Time to maximum measured plasma concentration
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Tmax of clavulanic acid for the test and the reference products
Time to maximum measured plasma concentration
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
T1/2 of amoxicillin for the test and the reference products
Elimination or terminal half-life
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
T1/2 of clavulanic acid for the test and the reference products
Elimination or terminal half-life
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Kel of amoxicillin for the test and the reference products
Elimination rate constant
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Kel of clavulanic acid for the test and the reference products
Elimination rate constant
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
AUCresid of amoxicillin for the test and the reference products
Residual area
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
AUCresid of clavulanic acid for the test and the reference products
Residual area
Measured: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start28 Jul 2018
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmtechnology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinPharmInvest, LLC
- Responsible party
- Sponsor
- Investigators
- Alexander Khokhlov, Professor, Principal investigator, ClinPharmInvest, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616301
- Sponsor's protocol ID
- FRM-04-AMOX version 2.0
- Status last verified
- Jul 2018
- First submitted
- 31 Jul 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Crossover, Two-period, Two-sequence, Single-center, Comparative 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
- ClinicalTrials.gov ID
- NCT03616301
- Acronym / sponsor ID
- FRM-04-AMOX version 2.0
- Conditions
- Bioequivalence
- Keywords
- bioequivalence, amoxicillin, clavulanic acid, Augmentin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Pharmtechnology LLCIndustry (pharma, biotech, devices)
- Collaborators
- ClinPharmInvest, LLC
- Study start
- 28 Jul 2018 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject will be randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.
Detailed description
The objective of this study is to establish if two formulations of amoxicillin + clavulanic acid combination are bioequivalent. Also monitoring, registration and evaluation of adverse events will be performed. The test formulation is Clavamox, powder for oral suspension, 400 mg + 57 mg / 5 ml (Pharmtechnology LLC, Belarus). The reference formulation is Augmentin®, powder for oral suspension, 400 mg + 57 mg / 5 ml (GlaxoSmithKline Trading CJSC, Russia).
56 healthy adult volunteers of both genders, with age ranging from 18 to 45 years old, will be divided into two cohorts with equal number of subjects (28). Each subject in a cohort will receive single dose (5 ml containing 400 mg of amoxicillin and 57 mg of clavulanic acid) of the test or the reference formulation with 200 ml of water after an overnight fast of at least 10 hours, according to the pre-defined randomization list, i. e. 14 subjects in each cohort will receive the test product and 14 subjects in each cohort will receive the reference product. Subjects will fast 4 hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period.
In each period blood samples will be collected before dosing and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing (total number: 19). The washout period is 7 days.
A validated HPLC/MS/MS method will be used to determine plasma concentrations of two analytes (amoxicillin and clavulanic acid).
ANOVA will be performed on log-transformed pharmacokinetic parameters Cmax, AUC0-t and 90% confidence interval will be constructed for the ratio of geometric least square means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for each analyte, both falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml | Experimental | Drug: ClavamoxClavamox, 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 | Drug: Augmentin®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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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 mass >45 kg and ≤100 kg
- non-breastfeeding women
- non-pregnant women
Key exclusion criteria (34 listed)
- Subjects with a known history of allergic disorders.
- Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients of the test and the reference product.
- Subjects with a known history of drug intolerance.
- History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to any of beta-lactam agents (e.g. a cephalosporin, carbapenem or monobactam).
- History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClavamoxClavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml, manufactured by Pharmtechnology LLC, Belarus | Drug | Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml |
| Augmentin®Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml, marketed by CJSC GlaxoSmithKline Trading, Russia | Drug | Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml |
Primary outcome
Cmax of amoxicillin for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Maximum concentration in plasma among observed concentrations at pre-specified time points
AUC0-t of amoxicillin for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
Cmax of clavulanic acid for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Maximum concentration in plasma among observed concentrations at pre-specified time points
AUC0-t of clavulanic acid for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
11 secondary outcomes
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
Time frame: 17 days
AUC0-∞ of amoxicillin for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
AUC0-∞ of clavulanic acid for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Tmax of amoxicillin for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Tmax of clavulanic acid for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
T1/2 of amoxicillin for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
T1/2 of clavulanic acid for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Kel of amoxicillin for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Kel of clavulanic acid for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
AUCresid of amoxicillin for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
AUCresid of clavulanic acid for the test and the reference products
Time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Khokhlov, Professor principal investigator
ClinPharmInvest, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clavamox and Augmentin® in people with Bioequivalence, run by Pharmtechnology LLC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of amoxicillin for the test and the reference products (time frame: Time points: 0,00 (within 30 minutes before dosing) and 0.25, 0.5, 0.75, 1.00, 1.25, 1.5, 1.75, 2.00, 2.33, 2.67, 3.00, 3.5, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00 hours after dosing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.