Parasitic disease
Conditions
Interventions
Sponsors
Fidson Healthcare Plc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject must meet the age requirements of 18 to 55 years when signing the initial informed consent form 2. Race/Ethnicity: Subjects can be of any ethnicity. 3. Males and/or non-pregnant, non-lactating females. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-HCG) pregnancy test performed within 28 days before the initial dose of study medication. Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history: postmenopausal with spontaneous amenorrhea for at least one (1) year, or spontaneous amenorrhea for less than one (1) year with serum FSH levels >40mIU/ml, or bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months or total hysterectomy and an absence of bleeding for at least 3 months. 3. Weight: Each subject is required to weigh at least 50 kg for men and 48 kg for women and have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 19.0 kg/m2. All weight values will be reported according to the scale’s precision (i.e. the nearest tenth or hundredth, 72.3 kg, 72.25 kg). 4. Non-smokers will be recruited 5. Adequate venous access in both arms for collecting blood samples during the study. 6. Able to understand and sign the written Informed Consent Form. Utilization of illiterate subjects is permitted when performed according to GCP, as well as regulations/guidance for the region of submission and country of conductance. 7. Willing to follow the protocol requirements and comply with protocol restrictions.
Exclusion criteria
Exclusion criteria: Subject candidates must not be enrolled in the study if they meet any of the following criteria: 1. Institutionalized subjects. 2. Social Habits: a. Ingestion of any alcoholic beverage within the 48 hours prior to the initial administration of study medication. b. Ingestion of any vitamins or herbal products within 7 days prior to the initial administration of the study medication. c. Any recent, significant change in dietary or exercise habits. d. History of drug and/or alcohol abuse within one year of the start of study. 3. Medications: a. Use of any prescription or over-the-counter (OTC) medications or dietary supplements containing Albendazole for at least 5 half-lives since last use or within the 14 days prior to the initial administration of study medication, whichever is greater. b. Use of any hormonal contraceptives, hormone replacement therapy, or any other steroidal hormonal therapy within 3 months prior to the initial dose of study medication. c. A depot injection or implant of any drug within 3 months prior to initial administration of study medication. d. Use of any other medication, herbal supplement, or vitamin known to induce or inhibit other hepatic enzyme activity within 28 days prior to the initial administration of study medication. 4. Diseases: a. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies, unless deemed not clinically significant by the Principal Investigator or Medical Sub-Investigator. b. History of tuberculosis. c. History of difficulties in swallowing or any gastrointestinal disease (i.e. cholecystectomy) which could affect drug absorption. d. History of gastrointestinal obstruction, particularly paralytic ileus. e. History of diabetes mellitus or impaired mono-/disaccharides tolerance. f. History of asthma. 8. Subjects who is on an investigational drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes: Cmax and AUC0-T of albendazole for the test and reference product | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax and AUC0-T of albendazole sulfoxide for the test and reference product | — |
Countries
Nigeria
Contacts
Public ContactBolakale Ayinde
Site Coordiantor
Outcome results
None listed