CTRI/2020/10/028508 [Registered on: 21/10/2020] Trial Registered Prospectively
Last Modified On:
07/11/2020
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A double blind,balanced, randomized,three treatment,three sequence,cross over study of next generation Ultrasol curcumin 20% in healthy adult human subjects under fasting conditions.
Scientific Title of Study
A double blind. balanced, randomized. single-dose, three-treatment, three-sequence, threeperiod,
crossover oral bioavailability study of Product A (Next Generation Ultrasol Curcumin 20% (50 mg total curcuminoids)), Product B (Next Generation Ultrasol Curcumin 20%(l00 mg
total curcuminoids)) compared with Product
C(Turmeric Extract 95%(1800 mg total curcuminoids)) in healthy adult human subjects under fasting condition.
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
DrSudhakar
Designation
Principal Investigator
Affiliation
ClinSync Clinical Research Pvt.Ltd
Address
Clinical Pharmacology Department,
ClinSync Clinical Research Pvt. Ltd.
JSR Mall, Plot No.7 to 18,
Madinaguda Village, Serilingampally MandaL,
Hyderabad, India. ClinSync Clinical Research Pvt. Ltd.
JSR Mall, Plot No.7 to 18,
Madinaguda Village, Serilingampally MandaL,
Hyderabad, India. Hyderabad TELANGANA 500050 India
Phone
040-29887005
Fax
040-29887005
Email
sudhakar.k@clinsynccro.com
Details of Contact Person Scientific Query
Name
DrSudhakar
Designation
Principal Investigator
Affiliation
ClinSync Clinical Research Pvt.Ltd
Address
Clinical Pharmacology Department,
ClinSync Clinical Research Pvt. Ltd.
JSR Mall, Plot No.7 to 18,
Madinaguda Village, Serilingampally MandaL,
Hyderabad, India. Clinical Pharmacology Department,
ClinSync Clinical Research Pvt. Ltd.
JSR Mall, Plot No.7 to 18,
Madinaguda Village, Serilingampally MandaL,
Hyderabad, India. Hyderabad TELANGANA 500050 India
Phone
040-29887005
Fax
040-29887005
Email
sudhakar.k@clinsynccro.com
Details of Contact Person Public Query
Name
KVMadhusudhan
Designation
Manager-Quality & Regulatory Affairs
Affiliation
M/s. ClinSync Clinical Research Pvt. Ltd.
Address
ClinSync Clinical Research Pvt. Ltd.
JSR Mall, Plot No.7 to 18,
Madinaguda Village, Serilingampally MandaL,
Hyderabad, India. ClinSync Clinical Research Pvt. Ltd.
JSR Mall, Plot No.7 to 18,
Madinaguda Village, Serilingampally MandaL,
Hyderabad, India. Hyderabad TELANGANA 500050 India
Phone
9550664434
Fax
040-29887005
Email
madhu.kv@clinsynccro.com
Source of Monetary or Material Support
Next Generation Ultrasol Curcumin 20% (50 mg total
curcuminoids)), Product B (Next Generation Ultrasol Curcumin 20%
(100 mg total curcuminoids))
ClinSync Clinical Research Pvt. Ltd.
JSR Mall, Plot No.7 to 18,
Madinaguda Village, Serilingampally Mandal, Hyderabad-500050,
Telangana, India.
Hyderabad TELANGANA
040-29887005
sudhakar.k@clinsynccro.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
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
healthy adult human
subjects under fasting condition.
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Product A: Next Generation Ultrasol Curcumin 20% (50 mg total curcuminoids)
Product B: Next Generation Ultrasol Curcumin 20% (100 mg total curcuminoids)
Product C: Turmeric Extract 95% (1800 mg total curcuminoids)
After an overnight fasting of at least 10.00 hours, six capsules of product
A (Next Generation Ultrasol Curcumin 20% (50 mg total
curcuminoids)) or Product B (Next Generation Ultrasol Curcumin 20%
(1 00 mg total curcuminoids)) or Product C (Turmeric Extract 95%
( 1800 mg total curcuminoids)) will be administered orally to the subjects
in sitting posture with at least 500 ± 2 mL water, at ambient temperature
in each period as per the randomization scheme.
Subjects will be instructed not to chew or crush the capsules and
swallow as a whole.
Dosing will be done under Yellow monochromatic light.
Compliance for dosing will be assessed by a thorough check of the oral
cavity immediately after dosing with torch & disposable spatula.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
55.00 Year(s)
Gender
Both
Details
Healthy, adult, human subjects within the age range of ≥18 to 55 years.
• Subjects with a BMI between 20.0-27.0 Kg/m2
• Participation is truly voluntary
Subjects should avoid food containing curcumin, black pepper at least 48 hrs before
dosing.
• Absence of disease markers of HIV 1 & 2, hepatitis B & C virus.
Absence of significant disease or clinically significant abnormal laboratory values
on laboratory evaluation, medical history, physical examination and systemic
examination during the screening
A normal 12-lead ECG
A normal chest X-ray (PA view) done within past 6 months.
Subjects have to be weight stable (weight change <3 kg during last 6 months).
Compliance with the requirement of the entire protocol
Subjects able to communicate effectively
Subjects willing to give written informed consent and adhere to all the requirements
of this protocol
Subject is a non-smoker and non-alcoholic
Additional inclusion criteria for female subjects:-
Female of childbearing potential practicing an acceptable method of birth control
for the duration of the study as judged by the investigator(s), such as condoms,
foams, jellies, diaphragm, intrauterine device (IUD), or abstinence: or
Postmenopausal for at least 1 year, or,
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or
hysterectomy has been performed on the subject).
ExclusionCriteria
Details
Institutionalized subjects.
History or evidence of hypersensitive to curcumin or its metabolites.
History or presence of any medical condition or disease according to the opinion of the physician.
History or evidence of chronic diseases such as diabetes, hypertension, metabolic syndrome, liver disorders, kidney disorders, pulmonary disease or infections,cardiovascular disease, pancreatic disease, infectious diseases, dermatological problems, arthritis and any cancer.
History of hypo and hyperthyroidism.
Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding,unintentional weight loss, anemia, dysphagia, or abdominal mass.
History of milk, gluten allergies or other known food intolerances and or any food allergies.
History of significant systemic diseases, seizures, psychiatric disorders, neurological
disorders, depression, or mental illness and allergic rash.
Exclusion of subjects taking ace- inhibitors, cholesterol lowering medications.
Subjects participating in aerobic exercise more than three times per week.
Habit of consuming high caffeine (more than 5 cups of coffee or tea/day)consumption.
History of difficulty with donating blood or difficulty in accessibility of veins.
History of addiction to any recreational drug or drug dependence.
Systolic blood pressure less than 90 mm Hg or more than 130 mm Hg.
Diastolic blood pressure less than 60 mm Hg or more than 80 mm Hg.
Pulse rate less than 60 beats per minute or more than 100 beats per minute.
Donation of blood (i.e. one unit or 350 mL) in the past 90 days before check-in.
Participation in a clinical research study within past 90 days of check-in.
Receipt of any prescription drugs or over-the-counter drugs (e.g.: cold preparations antacid preparations and natural products used for therapeutic benefits) within 30 days prior to screening.
Use of supplements containing curcumin or its metabolites 30 days prior to period I dosing and during the study duration.
Major illness during 90 days before check-in.
History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to check-in of period.
An unusual or abnonnal diet within 48.00 hours prior to check-in of each period, for whatever reason e.g. because of fasting due to religious reasons.
Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study.
Consumption of food and beverages containing xanthine (chocolates, tea, coffee or cola drinks) for at least 48.00 hours prior to check-in of each period.
Consumed grapefruit and grapefruit like citrus fruit (mosumbi/sweet lime) or juice within the 7 days prior to check-in of each period.
Positive results for drugs of abuse (benzodiazepi nes, opioids, amphetamines,
cannabinoids, cocaines and barbiturates) in urine during the check-in of each period.
• Positive results for urine alcohol analysis during the check-in of each period.
• Difficulty in swallowing solids dosage forms like tablets or capsules.
Additional exclusion criteria for female subjects,
Volunteer demonstrating a positive pregnancy test.
Volunteers who arc pregnant, currently breast-feeding or who are likely to become pregnant during the study.
Volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 30 days before dosing.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Relative absorption will be calculated using AUC values for Product A compared with Product C and Product B compared with Product C
Pk samples will be collected at -4.00,0.00,0.50,1.00,2.00,3.00,4.00,5.00,6.00,8.00,10.00,12.00, and 24.00 hours after drug administration
Secondary Outcome
Outcome
TimePoints
To monitor the adverse events and to ensure the safety of the
subjects.
1. To compare the bioavailability/relative absorption of total curcuminoids from a single oral dose of curcumin fonnulations -Product A (Next Generation Ultrasol Curcumin 20% (50 mg total curcuminoids)) with Product C (Tunneric Extract 95% (1800 mg total curcuminoids)) in healthy adult human subjects under fasting condition.
2. To compare the bioavailability/relative absorption of total curcuminoids from a single oral dose of curcumin formulations -Product B (Next Generation Ultrasol Curcumin 20% (100 mg total curcuminoids)) with Product C (Turmeric Extr<1ct 95% (1800 mg total curcuminoids)) in healthy adult human subjects under fasting condition.
Secondary objective:
To monitor the adverse events and to ensure the safety of the subjects.
Investigational Products
Product A: Next Generation Ultrasol Curcumin 20% (50 mg total curcuminoids) equally divided m six capsules as 8.34 mg total curcuminoids/ capsule manufactured by OmniActive Health Technologies Ltd., India.
Product B: Next Generation Ultrasol Curcumin 20% (100 mg total curcuminoids) equally divided m SIX capsules as 16.67 mg total curcuminoids/ capsule manufactured by OmniActive Health Technologies Ltd., India
Product C: Turmeric Extract 95% (1800 mg total curcuminoids) equally divided m six capsules as 300 mg total curcuminoids/ capsule. CURCUMIN C3 COMPLEX® was procured from Sabinsa Corporation and study capsules manufactured by OmniActive Health Technologies India
No of Subjects: 24 healthy adult human subjects will be included in the study. Additionally, 02 stand-by subjects will be included in order to dose 24 subjects in period - I.
Study design:
A double blind, balanced, randomized, single-dose, three-treatment, three-sequence, three-period, crossover oral bioavailability study in healthy adult human subjects under fasting condition.
Housing: The subjects will be housed for at least -60.00 (Day -3) hours prior to investigational product administration and up to 24.00 hours (Day 1) post dose in each period.
No of periods: 03.
Study Duration: The study duration will be for approximately 21 days,which shall include from period I check-in to post study safety assessment with a washout period of 07 days.