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CTRI Number  CTRI/2019/02/017469 [Registered on: 05/02/2019] Trial Registered Prospectively
Last Modified On: 13/06/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study to compare Bioavailability of Hydrocortisone 25 mg and 45 mg Suppository with Hydrocortisone foam and tablet in Healthy Adult Volunteers  
Scientific Title of Study   Relative Bioavailability Study of Hydrocortisone Acetate 25 mg and 45 mg Suppository in Healthy Adult Volunteers  
Trial Acronym  CO180008 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
RA-VP-000-430, Version 3.1, 22/Jan/2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmadabad GUJARAT India

Ahmadabad
GUJARAT
382210
India 
Phone  9726434204  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmadabad GUJARAT India


GUJARAT
382210
India 
Phone  9726434204  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmadabad GUJARAT India


GUJARAT
382210
India 
Phone  9726434204  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Genus Lifesciences Inc. 514 North, 12th Street Allentown, PA 18102 
 
Primary Sponsor  
Name  Genus Lifesciences Inc 
Address  514 North, 12th Street Allentown, PA 18102  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manish Agarwal   Medilink Hospital   309, 3 floor, Medilink Hospital, Near Shyamal Cross, Road, 132 ft Ring Road, Satellite Ahmedabad, 380015 Gujarat India
Ahmadabad
GUJARAT 		 919825443397

medilinkhospital@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medilink Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Fasting 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hydrocortisone acetate   Single administration of R1- Pramoxine hydrochloride 1% topical aerosol foam for anal use [Proctofoam® HC] Single administration R2- Hydrocortisone tablets (40 mg - 2 X 20 mg tablets) 
Intervention  Hydrocortisone acetate  Single rectal administration of T1 - Hydrocortisone acetate 25 mg suppository and T2 -Hydrocortisone acetate 45 mg suppository on 2 separate periods 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 Addison’s Disease, Cushing’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 <90 mmHg or a diastolic blood pressure >95 mmHg during Screening
11. Heart rate at rest of <50 beats per minute (bpm) or >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. Consumption of alcohol-containing foods or beverages within the 60 hours prior to Day-1 and throughout the study and the consumption of caffeine-containing foods or beverages within the 12 hours prior to Day-1 and throughout the remainder of the study
21. In the Principal Investigator’s opinion, have been on an abnormal diet (for whatever reason) during the 28 days prior to Day -1 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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)  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 Outcome  
Outcome  TimePoints 
To evaluate the safety and tolerability of a single rectal administration of hydrocortisone acetate suppository  Days 1, 8, 15, and 22 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2019 
Date of Study Completion (India) 24/05/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Relative Bioavailability Study of Hydrocortisone Acetate 25 mg and 45 mg Suppository in Healthy Adult Volunteers. This is a single-center, randomized, open-label, single-dose, 4-treatment, 4-period, 4-sequence crossover study with a 1-week washout between periods to be conducted in 20 healthy adult volunteers. The primary objective is 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)

 
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