Amoxicillin and Minocycline are marketed antibiotic to fight bacterial infections. MedDRA version: 12 Level: SOC Classification code 10002737 Term: Antibiotic Resistant Strain
Conditions
Interventions
Trade Name: Amoxil capsules 250mg
Product Name: Amoxil Capsules 250mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: amoxicillin
CAS
Sponsors
Helperby Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged between 18 and 40 years. 2. Following verbal & written information about the trial, the subject has signed & dated informed consent before any study related activity was carried out. 3. Subject legally competent and able to communicate effectively with the study personnel 4. Normal finding in the medical history and physical examination, unless the investigator considers an abnormality to be clinically irrelevant. 5. Male or female subjects who are using a medically acceptable method of contraception or of non-childbearing potential (i.e., surgically sterile-bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing or naturally postmenopausal for at least one year with a Screening FSH level = 40 mIU/L). A negative serum pregnancy test is required at Screening for females. Female subjects Female subjects of childbearing potential must use medically acceptable methods of contraception from the time of the first administration of the study medication until 3 months following administration of the last application of study medication. Acceptable methods include: • Oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or sub-dermal implants and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}: • A documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and the use of a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}; • Medically prescribed topically-applied transdermal contraceptive patch and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}; • Documented tubal ligation (female sterilisation). In addition, a barrier method {condom or occlu-sive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository} should also be used; • Double barrier method: Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; • Abstinence. Male subjects • Male subjects must use medically acceptable methods of contraception if their female partners are pregnant from the time of the first administration of the study medication until 3 months following administration of the last application of study medication. Acceptable methods include: • Condom • If the subject has undergone surgical sterilisation (vasectomy with documentation of azoosper-mia) a condom with spermicidal foam/gel/film/cream/suppository should also be used. • Use acceptable methods of contraception if the male subject’s partner could become pregnant from the time of the first administration of study medication until 3 months following administration of the last application of study medication. The acceptable methods of contraception are as follows: • Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; • Surgical sterilisation (vasectomy with documentation of azoospermia) and
Exclusion criteria
Exclusion criteria: 1. Regular use of medication, except contraceptive, vitamin tablets, treatment with antimicrobial agents within the 3 months preceding the study, Use of antibiotics for 4 weeks prior to the study drug application or use of concomitant systemic or topical antibiotics, Systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral Subject Restrictions. 2. Participation in a trial with another investigational drug within the 3 months preceding the study 3. Present or residual gastrointestinal, renal insufficiency or hepatic disorder 4. Abnormal pathology of nasal passages 5. Any clinically significant allergy or drug intolerance 6. Active hay fever, on-going cold/flu symptoms, including rhinitis at screening (visit 2) 7. Any medical history of renal insufficiency or hepatic disorder or other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs 8. history of hypersensitivity to beta-lactams or tetracycline 9. pregnant or breast-feeding women 10. Subjects known or suspected of not being able to comply with trial protocol (e.g. alcoholism, drug dependency, or psychological state). History of regular alcohol consumption exceeding an average weekly intake of alcohol greater than 21 units for female and 28 units for male. One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine. 11. Subjects with known or suspected immunodeficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of minocycline and amoxicillin administration on the proportions and types of cultivable antibiotic resistant bacteria that emerges in the oropharynx, anterior nares, on the skin and in the intestinal tract of humans. ; Secondary Objective: -To investigate the dynamics of resistance development by sampling on several occasions. -To ascertain the effect of minocycline and amoxicillin administration on the composition of the cultivable microbiota at a number of body sites. -To determine the concentration of minocyline/ amoxicillin at relevant body sites. ;Primary end point(s): To assess the effect of minocycline and amoxicillin administration on the proportions and types of cultivable antibiotic resistant bacteria that emerges in the oropharynx, anterior nares, on the skin and in the intestinal tract of humans. | — |
Countries
United Kingdom
Outcome results
None listed