None listed
Conditions
Interventions
Intervention1: Hydrocortisone acetate: Single rectal administration of T1 - Hydrocortisone acetate 25 mg suppository and T2 -Hydrocortisone acetate 45 mg suppository on 2 separate periods
Control Inte
Sponsors
Genus Lifesciences Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy males or females of any race, 18-55 years of age (both inclusive) at screening 2. BMI of 18.5-30.0 kg/m2 (both inclusive) 3. If a woman of child-bearing potential, have a negative serum pregnancy test at screening and a negative urine pregnancy test at check in on Day-1. 4. From the time of screening until 30 days after the last study dose, subjects must be sexually inactive, sterile, or using effective methods of contraception as follows: If the subject is a male with a female sexual partner who is of childbearing potential, the couple is willing to use two effective methods of birth control during the duration of the trial and for one month after the final evaluation or early termination. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must agree to use two effective methods of contraception for the duration of the study and at least 1 month after the final evaluation or early termination. The two forms of birth control authorized are defined as the use of a barrier method of contraception (condom with spermicide) in association with one of the following methods of birth control: bilateral tubal ligation; combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives with a stable dose for at least 1 month prior to check-in on Day 1; hormonal intra-uterine device (IUD) inserted at least 1 month prior to check-in for Period 1 on Day -1 5. Willing to participate in the study, able to understand and likely to complete all study requirements, and willing to provide voluntary informed consent before initiation of any study-related procedures 6. In the opinion of the Principal Investigator, able to fully comply with the study requirements and judged to be healthy on the basis of the medical history and screening procedures (physical examination, vital signs, and safety laboratory test results) 7. Negative test for selected drugs of abuse at Screening visit and check-in on Day-1 8. Negative test for alcohol breath test at check-in on Day -1 9. Negative hepatitis panel and negative Human Immunodeficiency Virus (HIV) antibody tests
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to dexamethasone, hydrocortisone, pramoxine, or any of the active or inactive ingredients in the drug treatment 2. Female who is pregnant or lactating, or is planning a pregnancy during the study, or if of child-bearing potential, is unwilling to adhere to the methods of contraception detailed above 3. Any abnormal laboratory value during screening or check-in on Day -1 that, in the opinion of the Principal Investigator, would interfere with the conduct of the study or safety of the subject 4. History or presence of any significant metabolic, allergic, cardiovascular, pulmonary, hepatic, renal, or hematologic (bleeding) disorders 5. History or presence of any significant gastrointestinal disorder (peptic ulcer disease, gastritis or bleeding diathesis, proctitis, colitis, inflammatory bowel disease, lower gastrointestinal bleeding, active hemorrhoids, and history of constipation or diarrhea/frequent bowel movements per day) within 60 days prior to Day -1 6. History or presence of any significant endocrine disorders (including Addisonâ??s Disease, Cushingâ??s Syndrome, and Cushingoid features) 7. History or presence of any significant immunologic, dermatologic, muscular, neurological, psychiatric, neoplastic, or other disease, which, in the opinion of the Principal Investigator, could interfere with the course of the study or expose the subject to undue risk by participating in this study 8. Currently participating or has participated within 30 days prior to screening in an investigational drug or device study 9. Inability to fully comply with the study protocol 10. Seated (after at least 5 minutes rest in a sitting position) systolic blood pressure >140 mmHg or 95 mmHg during Screening 11. Heart rate at rest of 100 bpm during Screening 12. Subjects who have a history of any of the following will be excluded: a. Allergy to dexamethasone, hydrocortisone, pramoxine, or to any ingredient in the test drugs b. HIV, hepatitis, or other blood-borne pathogens c. Liver damage or renal impairment 13. Prior or current corticosteroid treatment (oral, inhaled, transdermal, injectable) within 1 month of screening and treatment 14. Prior or current rectal corticosteroid treatment within 6 months of screening and treatment 15. Use of any prescription medications/products, or over-the-counter(OTC)/non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within the 14 days prior to Day -1, or 5 half-lives, whichever is longer, unless deemed acceptable by the Principal Investigator in consultation with the Sponsor Medical Monitor 16. Any significant rectal pathology that, in the opinion of the Principal Investigator or designee, would be a contraindication (or warning) with a hydrocortisone acetate suppository, including rectal obstruction, abscess, perforation, active fungal infection(s) and/or bacterial infection(s) 17. Anal or rectal surgery within the previous 2 years 18. Use of anorectal medications, including creams, ointments, suppositories, foams, and enemas or insertion of any medication or object into the rectum from the time of screening through the end of study 19. Receipt of blood products within 2 months prior to Day -1 20. Consumpt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the bioavailability of hydrocortisone following rectal administration of hydrocortisone acetate 25 mg and 45 mg suppository (test product) relative to the reference products (hydrocortisone acetate 1% and pramoxine hydrochloride 1% topical aerosol foam [Proctofoam®] and hydrocortisone oral tablets)Timepoint: Blood samples will be collected on Days 1, 8, 15, and 22; at -0.50, -0.25, and 0 (immediately prior to dosing) and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, and 24 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of a single rectal administration of hydrocortisone acetate suppositoryTimepoint: Days 1, 8, 15, and 22 | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed