CTRI/2024/02/062928 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On:
18/09/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A study to determine bioavailability and safety of ND 10 (7 Methylxanthine a caffeine derivative)
Extended Release Tablets 500 mg
Scientific Title of Study
An open label balanced randomized two-treatment two-period two-sequence multiple-dose steady state crossover comparative bioavailability study of ND 10 (7-Methylxanthine, a caffeine derivative) Extended-Release Tablets 500 mg of Theialife Sciences comparing with ND 10 (7-Methylxanthine a caffeine derivative) Immediate Release Tablets 400 mg of Theialife Sciences in healthy adult human subjects under fed conditions
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
24-002, Version 01 Date 22 Jan 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Chodisetti S S Viprusha
Designation
Principal investigator
Affiliation
Jeevan Scientific Technology Ltd
Address
Jeevan Scientific Technology Ltd
B 17 TIE Phase II Balanagar
Hyderabad Telangana India
Hyderabad TELANGANA 500037 India
Phone
04067364700
Fax
Email
sudha.chodisetti@jeevanscientific.com
Details of Contact Person Scientific Query
Name
Dr Chodisetti S S Viprusha
Designation
Principal investigator
Affiliation
Jeevan Scientific Technology Ltd
Address
Jeevan Scientific Technology Ltd
B 17 TIE Phase II Balanagar
Hyderabad Telangana India
Hyderabad TELANGANA 500037 India
Phone
04067364700
Fax
Email
sudha.chodisetti@jeevanscientific.com
Details of Contact Person Public Query
Name
Dr Chodisetti S S Viprusha
Designation
Principal investigator
Affiliation
Jeevan Scientific Technology Ltd
Address
Jeevan Scientific Technology Ltd
B 17 TIE Phase II Balanagar
Hyderabad Telangana India
Hyderabad TELANGANA 500037 India
Phone
04067364700
Fax
Email
sudha.chodisetti@jeevanscientific.com
Source of Monetary or Material Support
Theialife Sciences (a Bioplus Life Sciences Pvt. Ltd group company) Pharmed Gardens, Whitefield Road, Bangalore -560 048, Karnataka, India
Primary Sponsor
Name
Dr AKBAR WAJID
Address
Theialife Sciences
(a Bioplus Life Sciences Pvt. Ltd group company)
Pharmed Gardens
Whitefield Road
Bangalore 560 048
Type of Sponsor
Other [Self]
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 Chodisetti S S Viprusha
Jeevan Scientific Technology Ltd
Clinical Pharmacology Department, Forth floor, B 17 TIE Phase II Balanagar
Hyderabad 500037 Telangana India Hyderabad TELANGANA
Dosing Day 01 to 05 (Thrice a day, 8 hours apart), Total of 1200 mg per day
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
Healthy adult human subjects between 18 to 45 years of age including both and weight greater than 50 Kg BMI 18.5 to 24.9 kg per m²
Acceptable findings during registration and screening including medical history, physical examination laboratory evaluations 12 lead ECG and Chest X Ray postero anterior view
Values within normal ranges of laboratory parameters upon evaluation by the Investigator or Physician
Subjects able to communicate effectively with study personnel
Subjects willing to give written informed consent and adhere to all the requirements of this protocol
Subject willing to abstain from all kinds of caffeine xanthine containing foods or grapefruit or grapefruit juice from 72 hours prior to admission until last blood sample collection in each study period
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 at least two weeks thereafter as judged by the investigator such as condoms foams jellies diaphragm and intrauterine device IUD or abstinence
ExclusionCriteria
Details
Subjects having a history of contraindication or hypersensitivity example anaphylaxis to ND 10 (7 Methylxanthine a caffeine derivative) or related group of drugs
A history of significant asthma urticaria or other allergic type reactions after taking aspirin or other NSAIDs
A history of seizures diabetes migraine hypertension cardiovascular pulmonary neurological or psychiatric disease disorder dermatological endocrine eye disorders immunological hepatic renal hematopoietic gastrointestinal ongoing infectious diseases or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
History of gastrointestinal GI inflammation, bleeding ulceration and perforation of the stomach small intestine or large intestine
History or evidence of exfoliative dermatitis Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
Have significant diseases or clinically significant abnormal findings during screening (medical history, physical examination (clinical examination) laboratory evaluations ECG chest Xray recording etc)
Any known enzyme inducing or inhibiting drug taken within 14 days before the study.
Participation in a drug research study within 90 days prior to admission of this study
Blood loss or whole blood donation within 90 days prior to drug administration
Consumption of high caffeine (more than 5 cups of coffee or tea per day)
History of addiction to any recreational drug or drug dependence
An unusual or abnormal diet, for any reason within 48 hours prior to admission of each period, e.g. fasting due to religious reasons
History of dehydration from diarrhea, vomiting or any other reason within a period of 72 hours prior to study admission of each period
Positive results for drugs of abuse (benzodiazepines cocaine opioids amphetamines cannabinoids and barbiturates) in urine during the study admission of each period
Positive results for alcohol (breath analysis urine alcohol blood alcohol) consumption test during the study admission of each study period
History of pre existing bleeding disorder
Difficulty in swallowing Investigational products
Difficulty with donating blood
Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg
Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg
Pulse rate less than 60 beats per minute or more than 100 beats per minute
Use of any prescription drugs within 07 days or at least 5 halflives of the compound whichever period is longer prior to study admission and use of any herbal medicines and any OTC medications including vitamins within 14 days or at least 5 halflives of the compound whichever period is longer prior to study admission
Symptoms of COVID19 or positive COVID19 test result within the past 30 days
Female subjects demonstrating a positive pregnancy screen
Female volunteer who is pregnant or currently breast feeding
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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Alternation
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To compare the bioavailability of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg of Theialife Sciences comparing with ND 10 (7 Methylxanthine, a caffeine derivative) Immediate Release Tablets 400 mg of Theialife Sciences in healthy adult human subjects under fed conditions
ER Tablets 500 mg On dosing day 3 and 4, two time points each day at 0 hours and at 12 hour On dosing day 5, 27 time points at 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,10,12,12.5,13,13.5,14,14.5,15,15.5,16,17,18,20,22 and 24 hours IR Tablets 400 mg On dosing day 3 and 4 two time points each day at 0 and 8 hours On dosing day 5, 34 time points at 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,8.5,9,9.5,10,10.5,11,11.5,12,13,14,16,16.5,17,17.5,18,18.5,19,19.5,20,21,22 and 24 hours
Secondary Outcome
Outcome
TimePoints
To assess the safety and tolerability of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg and ND 10 (7 Methylxanthine a caffeine derivative) Immediate Release Tablets 400 mg in normal healthy adult human subjects under fed conditions
ER Tablets 500 mg On dosing day 3 and 4, two time points each day at 0 hours and at 12 hour On dosing day 5, 27 time points at 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,10,12,12.5,13,13.5,14,14.5,15,15.5,16,17,18,20,22 and 24 hours IR Tablets 400 mg On dosing day 3 and 4 two time points each day at 0 and 8 hours On dosing day 5, 34 time points at 0,0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,8.5,9,9.5,10,10.5,11,11.5,12,13,14,16,16.5,17,17.5,18,18.5,19,19.5,20,21,22 and 24 hours
Target Sample Size
Total Sample Size="14" Sample Size from India="14" Final Enrollment numbers achieved (Total)= "14" Final Enrollment numbers achieved (India)="14"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Subjects will undergo a screening procedure comprising 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.