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CTRI Number  CTRI/2024/09/074200 [Registered on: 23/09/2024] Trial Registered Prospectively
Last Modified On: 19/09/2024
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   To compare the rate and extent of absorption of Dexamethasone 20 mg Tablets  
Scientific Title of Study   An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, oral bioequivalence study of Dexamethasone 20 mg Tablets of GALENpharma GmbH, Germany, comparing with Fortecortin® 4 mg tablets (5 × 4 mg tablets) of Merck Healthcare Germany GmbH, Waldstraße 3, 64331 Weiterstadt, in normal, healthy, adult, human subjects under fed conditions 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
23-107 Version 01 dated 03 Jan 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mallu Maheswara Reddy MBBS 
Designation  Principal Investigator 
Affiliation  Jeevan Scientific Technology Limited 
Address  Jeevan Scientific Technology Ltd B 17 TIE Phase II Balanagar

Hyderabad
TELANGANA
500037
India 
Phone  04067364700  
Fax    
Email  maheswara.mallu@jeevanscientific.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mallu Maheswara Reddy MBBS 
Designation  Principal Investigator 
Affiliation  Jeevan Scientific Technology Limited 
Address  Jeevan Scientific Technology Ltd B 17 TIE Phase II Balanagar

Hyderabad
TELANGANA
500037
India 
Phone  04067364700  
Fax    
Email  maheswara.mallu@jeevanscientific.com  
 
Details of Contact Person
Public Query  
Name  Dr Mallu Maheswara Reddy MBBS 
Designation  Principal Investigator 
Affiliation  Jeevan Scientific Technology Limited 
Address  Jeevan Scientific Technology Ltd B 17 TIE Phase II Balanagar

Hyderabad
TELANGANA
500037
India 
Phone  04067364700  
Fax    
Email  maheswara.mallu@jeevanscientific.com  
 
Source of Monetary or Material Support  
M/s. GALENpharma GmbH Wittland13 Kiel (Germany) - 24109 
 
Primary Sponsor  
Name  GALENpharma GmbH 
Address  GALENpharma GmbH Wittland 13 24109 Kiel GERMANY  
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 Mallu Maheswara Reddy MBBS  Jeevan Scientific Technology Ltd  Jeevan Scientific Technology Ltd B 17 TIE Phase II Balanagar
Hyderabad
TELANGANA 		 04067364700

maheswara.mallu@jeevanscientific.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maarg Independent ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Fed 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexamethasone 20 mg Tablets   Strength: 20 mg; Dose: 20 mg 
Comparator Agent  Fortecortin® 4 mg tablets  Strength: 4 mg; Dose: 20 mg (5 × 4 mg tablets) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Healthy, adult human subjects 18-45 years of age (both inclusive), and weight ≥50 Kg (BMI 18.5 to 30.0 kg/m² (including both)).
2.Acceptable findings during registration and screening including, medical history, physical examination, laboratory evaluations, 12- lead ECG and chest X-Ray (postero-anterior view).
3.Non-smokers and non-alcoholic.
4.Values within normal ranges for laboratory parameters upon evaluation by the investigator or physician.
5.Subjects able to communicate effectively.
6.Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
7.Subject willing to abstain from all kinds of caffeine/xanthine containing foods or grapefruit or grapefruit juice from 72.00 hours prior to admission until the last post dose blood sample collection in each period.
8.Female subjects:
•Postmenopausal for at least 1 year or
•Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject) or
•Female of childbearing potential practicing an acceptable method of birth control for the duration of the study and at least two weeks thereafter as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, and intrauterine device (IUD) or abstinence. 
 
ExclusionCriteria 
Details  1.Volunteers having history of contraindication or hypersensitivity (e.g., anaphylaxis) to dexamethasone or related group of drugs.
2.A history of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
3.A history of seizures, diabetes, migraine, osteoporosis, myasthenia gravis, cardiovascular (including hypertension and heart failure), pulmonary, neurological or psychiatric disease/disorder (including risk of suicide, also in the anamnesis), dermatological, endocrine, eye disorders (e.g., narrow- and wide-angle glaucoma, corneal ulcer and corneal injury), immunological (including immunosuppressed volunteers), hepatic, renal, hematopoietic, gastrointestinal (including enteroanastomosis), malignant, ongoing infectious diseases, history of tubercolosis, lymphadenitis after BCG vaccination, HbsAg-positive chronic active hepatitis, systemic mycoses and parasitosis or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
4.History of gastrointestinal (GI) inflammation (including ulcerative colitis and diverticulitis), bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine.
5.History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
6.Eight weeks before until two weeks after vaccination with live vaccines.
7.Any known enzyme inducing or inhibiting drug taken within 30 days before the study.
8.Participation in a drug research study within 90 days prior to dosing of this study.
9.Blood loss or whole blood donation within 90 days prior to drug administration.
10.Consumption of high caffeine (more than 5 cups of coffee or tea/day).
11.History of addiction to any recreational drug or drug dependence.
12.An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g., fasting due to religious reasons.
13.History of dehydration from diarrhea, vomiting or any other reason within a period of 72.00 hours prior to study admission of each period.
14.Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the study admission of each period.
15.Positive results for alcohol consumption tests during the study admission of each period.
16.History of pre-existing bleeding disorder.
17.Difficulty with donating blood.
18.Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
19.Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
20.Pulse rate less than 60 beats/minute or more than 100 beats/minute.
21.Use of any prescribed medication or OTC medicinal products including vitamins and herbal medicinal products during last two weeks preceding the first dosing.
22.Female volunteer who is pregnant, currently breast-feeding.
23.Female volunteers demonstrating a positive pregnancy test.
24.Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
25.Symptoms of COVID-19 or positive COVID-19 test result within the past 30 days.
26.History of rare hereditary problems of galactose intolerance, fructose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase deficiency. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the rate and extent of absorption of Dexamethasone 20 mg Tablets of GALENpharma GmbH, Germany, with Fortecortin® 4 mg tablets (5 × 4 mg tablets) of Merck Healthcare Germany GmbH, Waldstraße 3, 64331 Weiterstadt, in normal, healthy, adult, human subjects under fed conditions  In each period, a total of 20 blood samples (05 mL of each) per subject will be collected at pre-dose (00.00 hour) and at 00.17, 00.33, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 06.00, 08.00, 10.00, 12.00, 16.00, and 24.00 hours post dose. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the safety and tolerability of single oral dose of Dexamethasone 20 mg Tablets in normal, healthy, adult, human subjects under fed conditions 
Clinical examination and vital signs (seated blood pressure, respiratory rate, radial pulse rate and body temperature) and well-being will be recorded at the time of admission and before discharge in each study period
Vital signs (seated blood pressure, radial pulse rate and body temperature) and well-being will be recorded at 00.00 (Pre dose), 02.00, 05.00 and 11.00 hours after dosing, within ±45 minutes of scheduled time in each study period. 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   All the subjects will undergo a screening procedure comprising of clinical examination, recording of electrocardiogram and laboratory investigation of blood as well as urine, which will be valid for 21 days from the day of screening. Radiological investigations (chest X-ray) will be repeated, if not done in the past 6 months or if clinically indicated at the time of screening. Subjects must be enrolled in the study only after providing written informed consent. Selection of subjects for the study will be done based on assessment against the inclusion and exclusion criteria. 
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