Overview

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

Status:
Completed
Trial end date:
2018-10-08
Target enrollment:
0
Participant gender:
All
Summary
This was an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject was 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.The study was conducted in multiple groups.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pharmtechnology LLC
Collaborators:
ClinPharmInvest CRO
ClinPharmInvest, LLC
Treatments:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
Clavulanic Acids
Criteria
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 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.

Exclusion Criteria:

- 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.

- 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.

- The values of standard laboratory and instrumental parameters that exceed reference
values of the local clinical laboratory