To Assess the Effect of AZD1722 on the Pharmacokinetics of Cefadroxil in Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any - 50 |
Updated: | 4/21/2016 |
Start Date: | May 2014 |
End Date: | August 2014 |
A Phase 1, Single-center, Randomized, 2-Way Cross-over, Open-label Study to Evaluate the Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Cefadroxil in Healthy Volunteers
A study to evaluate the effect of repeated oral doses of AZD1722 on the pharmacokinetics of
Cefadroxil
Cefadroxil
A Phase 1, Single-center, Randomized, 2-Way Cross-over, Open-label Study to Evaluate the
Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Cefadroxil in
Healthy Volunteers
Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Cefadroxil in
Healthy Volunteers
Inclusion Criteria:- 1. Healthy male and female volunteers aged ≥18 years to ≤50 years
(inclusive) with suitable veins for cannulation or repeated venepuncture 2. Females could
be of non-childbearing potential and child bearing potential Females of non-child bearing
potential should be Post-menopausal, documentation of irreversible surgical sterilization
by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
Females of childbearing potential must have a negative pregnancy test at screening and
must not be lactating, using one of the following effective methods to avoid pregnancy
during the treatment periods, must have an established use of oral, injected, or implanted
hormonal methods of contraception, placement of an intrauterine device (IUD) or
intrauterine system, use a barrier method of contraception: condom or occlusive cap
(diaphragm or cervical/vault caps) with spermicidal. Male healthy volunteers with a
partner of childbearing potential must agree to avoid fathering a child, and refrain from
donating sperm, from the first day of dosing until at least 3 months after last dose of
investigational product, and therefore be either sterile (with the appropriate
post-vasectomy documentation of the absence of sperm in the ejaculate) or agree to use,
one of the following approved methods of contraception: a male condom with spermicide; a
sterile sexual partner or use by female sexual partner of an acceptable form of effective
contraception (see above) 3. Have a body mass index (BMI) ≥18 and ≤30 kg/m2 and weigh at
least 50 kg and no more than 100 kg Exclusion Criteria: 1.History of any clinically
significant disease or disorder which, in the opinion of the principal investigator, may
either put the healthy volunteer at risk because of participation in the study, or
influence the results or the healthy volunteer's ability to participate in the study.
2.History or presence of GI, hepatic or renal disease including GI surgery other than
appendectomy or any other condition known to interfere with absorption, distribution,
metabolism or excretion of drugs. 3.Any clinically significant illness, medical/surgical
procedure or trauma within 4 weeks of the first administration of the investigational
product. 3 History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity,
as judged by the principal investigator or history of hypersensitivity to drugs with a
similar chemical structure or class to AZD1722 or cefadroxil. 4. Has received another new
chemical entity (defined as a compound which has not been approved for marketing) or has
participated in any other clinical study that included drug treatment within at least 30
days of the first administration of investigational product in this study. 5. Loose stools
for ≥2 days in the past 7 days before investigational product administration. Use of
medications that are known to affect stool consistency and/or GI motility, including fibre
supplements, anti diarrheals, prokinetic drugs, enemas, probiotic medications or
supplements; or salt or electrolyte supplements containing sodium, potassium, chloride, or
bicarbonate formulations during the past 7 days before randomization
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