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CTRI Number  CTRI/2021/03/031661 [Registered on: 02/03/2021] Trial Registered Prospectively
Last Modified On: 19/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative pharmacokinetic exposure evaluation of two formulations of Remdesivir in healthy adult human subjects. 
Scientific Title of Study   A Randomized, Open Label, Balanced, Two-Treatment, One-Sequence, One-Period, Single Dose, Parallel design, Comparative Pharmacokinetic Exposure Evaluation Study of Test Product (T) [Remdesivir Sublingual Tablet 20 mg (JGL2020) (Dose 100 mg administered as 5 sublingual tablets X 20 mg) of Jubilant Generics Limited, India] with Reference Product (R) [Jubi-RTM (Remdesivir for injection 100 mg) (Dose 100 mg intravenous infusion) of Jubilant Generics Limited, India] in Healthy Adult, Human Subjects, Under Fasting Conditions. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
REMD-20-014 Version 05 dated 30-12-2020  Protocol Number 
REMD-20-014 Version 06 dated 20-01-2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prateek Gupta 
Designation  Assistant Manager Medical, Clinical Pharmacology 
Affiliation  Jubilant Generics Limited 
Address  Jubilant Generics Limited C 46 Sector 62 Noida UP 201307
Department: Clinical Pharmacology Jubilant Generics Limited C 46 Sector 62 Noida UP 201307
Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  9871408298  
Fax    
Email  prateek.gupta@jubl.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prateek Gupta 
Designation  Assistant Manager Medical, Clinical Pharmacology 
Affiliation  Jubilant Generics Limited 
Address  Jubilant Generics Limited C 46 Sector 62 Noida UP 201307
Department: Clinical Pharmacology Jubilant Generics Limited C 46 Sector 62 Noida UP 201307
Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  9871408298  
Fax    
Email  prateek.gupta@jubl.com  
 
Details of Contact Person
Public Query  
Name  Dr Prateek Gupta 
Designation  Assistant Manager Medical, Clinical Pharmacology 
Affiliation  Jubilant Generics Limited 
Address  Jubilant Generics Limited C 46 Sector 62 Noida UP 201307
Department: Clinical Pharmacology Jubilant Generics Limited C 46 Sector 62 Noida UP 201307
Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  9871408298  
Fax    
Email  prateek.gupta@jubl.com  
 
Source of Monetary or Material Support  
Jubilant Generics Limited D-12, Sector – 59 Noida – 201 301 UP, India 
 
Primary Sponsor  
Name  Jubilant Generics Limited 
Address  D 12 Setor 59 Noida, UP 201301 India 
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 
Prateek Gupta  Jubilant Generics Limited  Department: Clinical Pharmacology C 46 Sector 62, Noida 210307 UP, India
Gautam Buddha Nagar
UTTAR PRADESH 		 9871408298
01204363000
prateek.gupta@jubl.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Good Society for Ethical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Remdesivir for injection 100 mg, single dose of 100 mg  Remdesivir for injection 100 mg, single dose of 100 mg Dose: 100mg Frequency: Once Route: Intravenous Duration: 120 minutes 
Intervention  Remdesivir sublingual tablets (JGL 2020), single dose of 100 mg  Remdesivir sublingual tablets (JGL 2020), single dose of 100 mg Dose: 100mg Frequency: Once Route: Sublingual (Oral) Duration: 45 minutes (5 Tablets of 20mg) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Subjects between 18 – 45 years of age (both inclusive).
2. Subjects who are able to read and write the vernacular language (English/Hindi) and understand the study requirements.
3. Must have provided written informed consent voluntarily for participation in the study in the subject’s vernacular language (English/Hindi).
4. Weight between 50.00 – 80.00 Kg in case of Male (both inclusive) or 45.00 –75.00 Kg in case of Female (both inclusive).
5. BMI 18.50 – 24.90 Kg/m2 (both inclusive).
6. Healthy as determined by medical history, clinical and laboratory examination performed within 21 days prior to admission for the study.
7. In the opinion of the Principal Investigator/Co-Investigator/Designee, be able to comply with the study procedures and protocol restrictions.
8. If female, and of childbearing potential (defined as a pre-menopausal female who is biologically capable of becoming pregnant), the subject must agree to practice a medically acceptable form of contraception from admission till close out visit of the clinical study. Acceptable forms of contraception include intrauterine devices, implant-able devices, and barrier methods. If a barrier method is chosen, a double barrier (e.g., condom plus foam) is required.

 
 
ExclusionCriteria 
Details  1. Known hypersensitivity or idiosyncratic reaction to Remdesivir, its excipients or similar classes of drugs.
2. Any evidence of significant abnormalities upon physical or clinical examination.
3. Laboratory values, which are significantly different from pre-defined reference ranges and judged clinically significant.
4. Consumption of grapefruit juice/ grapefruit at least 48-hours prior to admission.
5. Any clinically significant abnormality in Chest X-Ray (PA view).
6. Any clinically significant abnormality in ECG.
7. Evidence of QT prolongation, QTc (Rate adjusted QT interval) > 450ms (in case of male) or 460ms (in case of female)
8. Serum alanine transaminase (ALT) levels above 2x upper limit of normal (ULN) or total bilirubin > 1.3x ULN or Serum creatinine levels above 1.5x upper limit of normal.
9. History of treatment with antiplatelet/anticoagulant/fibrinolytic agents.
10. Past or present use of tobacco and nicotine in any form.
11. History of drug dependence or excessive alcohol intake on a habitual basis, or, inability to abstain from alcohol for the entire duration of study period.
12. History or presence of significant gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, hematologic, or endocrine disease.
13. History of allergy to Heparin, dye and preservatives.
14. History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension, glaucoma etc.
15. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses and syphilis.
16. Positive result for drug(s) of abuse testing (amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol, morphine, and cocaine) in urine.
17. Positive test for alcohol upon breath analyser testing.
18. History or presence of any allergic illness including allergic skin diseases, allergic asthma and drug-induced allergy, e.g., allergy due to amoxicillin, ampicillin, penicillin, tetracycline and Non-steroidal anti-inflammatory drugs (like ibuprofen and naproxen) etc.
19. History of intake/administration of any investigational treatment in a clinical study within last 90 days prior to the onset of the study admission.
20. History of significant blood loss (≥ 350 mL) due to any reason, including blood donation within last 90 days prior to admission of the study.
21. History or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
22. Existence of any surgical or medical condition which in the judgement of Principal Investigator/Designee might interfere with the absorption, distribution, metabolism or elimination of the study drug, or, is likely to compromise the safety of subject.
23. Intake of any enzyme-modifying drugs such as cimetidine, theophylline, benzodiazepines, ranitidine, repaglinide, midazolam, proton pump inhibitors, antacids, erythromycin, diuretics, ketoconazole, anti-hypertensive drugs, dopamine agonists, busulfan, bile acid sequestrants, aluminum containing antacids, agents metabolized by CYP3A4, CYP2C8 and CYP1A2, agents Inducing UDP-glucuronosyltransferase (UGT) Metabolism, Cholestyramine etc. within 30 days of study drug administration, or, administration/intake of any prescription or OTC drug including vitamins and natural supplements within 30 days of study drug administration. In such cases, subject selection will be at the discretion of the Principal Investigator/Designee.
24. Intake of unusual diet for two weeks prior to admission and not willing to avoid consumption of such diet till the completion of close-out visit of the study. In such cases, subject selection will be at the discretion of the Principal Investigator/Designee.
25. Difficulty in swallowing tablets / capsules.
26. Female subjects whose menstrual cycle coincides with the dosing day during the study period.
27. Pregnant and lactating females.
28. Presence of dentures, tongue piercings with ongoing use of tongue studs/jewelry, orthodontic braces, or surgical manipulations of the tongue
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cmax, AUC 0 t and AUC 0 inf , For Nucleoside Metabolite (GS-441524)  Pre dose and at 0.085, 0.17, 0.25, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 1.87, 2.00, 2.085, 2.17, 2.33, 2.50, 2.75, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00,
16.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours post dose
 
 
Secondary Outcome  
Outcome  TimePoints 
Tmax, T1 by 2el, Kel, AUC Extrap, TLIN and LQCT, For Nucleoside Metabolite (GS
441524)
Cmax, AUC0 t AUC0 inf, Tmax, T1 by 2el, Kel, AUC Extrap, TLIN and LQCT, For Remdesivir (GS-5734)
 		 Pre dose and at 0.085, 0.17, 0.25, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 1.87, 2.00, 2.085, 2.17, 2.33, 2.50, 2.75, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00,
16.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours post dose
 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   03/03/2021 
Date of Study Completion (India) 08/03/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 08/03/2021 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is a randomized, open label, balanced, two-treatment, one-sequence, one-period, single dose, parallel design, comparative pharmacokinetic exposure evaluation study of test product (T) [Remdesivir sublingual tablet 20 mg (JGL2020) (Dose 100 mg administered as 5 sublingual tablets X 20 mg) of Jubilant Generics Limited, India] with reference product (R) [Jubi-RTM (Remdesivir for injection 100 mg) (Dose 100 mg intravenous infusion) of Jubilant Generics Limited, India] in Healthy Adult, Human Subjects, Under Fasting Conditions


The objective of the trail is to characterize and compare the pharmacokinetic exposure of the test formulation [Remdesivir Sublingual Tablet 20 mg (JGL2020) (Dose 100 mg administered as 5 sublingual tablets X 20 mg) of Jubilant Generics Limited, India] with reference formulation [Jubi-RTM (Remdesivir for injection 100mg) (Dose 100 mg intravenous

infusion) of Jubilant Generics Limited, India] in healthy adult, human subjects, under fasting Conditions. Safety of the study subjects will also be monitored and evaluated

 
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