CTRI/2019/07/020467 [Registered on: 31/07/2019] Trial Registered Prospectively
Last Modified On:
11/03/2020
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
2 PERIOD FASTING STUDY IN HEALTHY, NORMAL, ADULT, HUMAN MALE, RANDOMLY DOSED IN EACH PERIOD WITH OLNP-18 OR STANDARD CURCUMINOIDS
Scientific Title of Study
A double-blind, randomized, balanced, two-treatments, two-sequence, two-period, two-way crossover, single dose oral comparative bioavailability study of OLNP-18 (Test product) with Standard curcuminoids (Reference product) following oral administration of hard gelatin capsules in normal, healthy, adult, human male study participants under fasting conditions.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr M Missamma
Designation
Clinical Pharmacologist, Clinical Research
Affiliation
Vimta Labs Ltd.
Address
Vimta Labs Ltd.
142, IDA, Phase II, Cherlapally
Hyderabad, INDIA
Vimta Labs Ltd.
Phase II, IDA, Cherlapally, Hyderabad-51 Hyderabad TELANGANA 500 051 India
Phone
91-40-27264141
Fax
Email
jeevadaya@vimta.com
Details of Contact Person Scientific Query
Name
Sanjib Kumar Panda
Designation
Chief Operating Officer
Affiliation
Olene Life Sciences Pvt. Ltd.
Address
Olene Life Sciences Pvt. Ltd., India,
A-Block,4th Floor ,Prince Info Park,
81 B,2nd Main Road (Opp Ambit Park),
Ambattur Industrial Estate,
Chennai,Tamil Nadu,India
No.325, 4th Floor, TCR Niveras Plaza, Poonamallee High Road, Aminjikarai, Chennai-600029, Tamilnadu, India
Chennai TAMIL NADU 600058 India
Phone
Fax
Email
info@olenelife.com
Details of Contact Person Public Query
Name
Sanjib Kumar Panda
Designation
Chief Operating Officer
Affiliation
Olene Life Sciences Pvt. Ltd.
Address
Olene Life Sciences Pvt. Ltd., India,
A-Block,4th Floor ,Prince Info Park,
81 B,2nd Main Road (Opp Ambit Park),
Ambattur Industrial Estate,
Chennai,Tamil Nadu,India
A-Block,4th Floor ,Prince Info Park, 81 B,2nd Main Road (Opp Ambit Park), Ambattur Industrial Estate, Chennai,Tamil Nadu,India Chennai TAMIL NADU 600058 India
Phone
Fax
Email
info@olenelife.com
Source of Monetary or Material Support
Olene Life Sciences Private Limited
Primary Sponsor
Name
Olene Life Sciences Private Limited
Address
A-Block,4th Floor ,Prince Info Park,
81 B,2nd Main Road (Opp Ambit Park),
Ambattur Industrial Estate,
Chennai-600058, Tamil Nadu
Type of Sponsor
Pharmaceutical industry-Indian
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 M Missamma
Vimta Labs Ltd.
142, IDA, Phase II, Cherlapally, Hyderabad-500 051, INDIA
Hyderabad TELANGANA
91-40-27264141
jeevadaya@vimta.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Naithika Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy, normal, adult, human male
Intervention / Comparator Agent
Type
Name
Details
Intervention
OLNP-18
OLNP-18, 4gm hard gelatin capsules (474 mg x 8 capsules) containing approximately 2g of total curcuminoids equivalents will be given orally. Total duration of the study is about 10 days in addition to the washout period of 7 days.
Comparator Agent
Standard curcuminoids
Standard curcuminoids 2.1gm hard gelatin capsules (263 mg x 8 capsules) containing approximately 2g of total curcuminoids equivalentswill be given orally. Total duration of the study is approximately 10 days in addition to the washout period of 7 days.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
1 Subject should provide written informed consent.
2 Subject must be a normal, healthy, adult human male 18 to 45 years of age.
3 Subject willing to consume 8 capsules of investigational product per period with 300 ± 2mL of water.
4 Subject should have a Body Mass Index of 18.5 kg/m2 to 24.9 kg/m2 with body weight at least 55 kg for men.
5 Subject should have a systolic blood pressure with an upper limit of less than 140 mmHg and lower limit of more than or equal to 100 mm Hg. Similarly diastolic blood pressure with an upper limit less than 90 mm Hg and lower limit more than or equal to 70 mmHg.
6 Subject should have heart rate not less than 60 beats/min and not more than 100 beats/min and respiratory rate not less than 14/min and not more than 18/min.
7 Subjects should be willing to take turmeric free food for the entire study duration
8 Subject must be of normal health as determined by medical history and physical examination performed within 21 days prior to the dosing of period-I.
9 Subject should have clinically insignificant ECG, chest X-ray and vital signs.
10 Availability of a study volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
11 With negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
ExclusionCriteria
Details
1 Subject is incapable of understanding the informed consent.
2 Subject having History of difficulty in swallowing capsules.
3 Subject has a history of hypersensitivity or idiosyncratic reaction to turmeric and active or inactive ingredient in the OLNP-18 or any other related product.
4 Subject has any evidence of impairment of renal, hepatic, cardiac, pulmonary or gastrointestinal function. Study volunteers with a history of tuberculosis, epilepsy, asthm, diabetes, psychosis or eye disorders will not be eligible for the study.
5 Subject regularly smokes more than 10 cigarettes daily or has difficulty in abstaining from tobacco for the duration of the study period.
6 Subject has taken over the counter or prescribed medications, including any enzyme modifying drugs (known to induce or inhibit hepatic enzyme activity) or any systemic medication within the past 30 days prior to dosing in first period.
7 Subject has a history of any psychiatric illness, which may impair the ability to provide written, informed consent.
8 Subject has a history of alcohol or substance abuse within the last 5 years.
9 Subject has clinically significant abnormal values of laboratory parameters.
10 Subject has participated in any other clinical investigation using experimental drug/product or had bled more than 350 mL in the past 03 months.
11 Subject is unable to or unlikely to be compliant with protocol requirements or restrictions.
12 Subject, in whom study product is contraindicated for medical reasons
13 Any other clinical condition like diarrhea or vomiting within 3 days prior to dosing;
14 Use of any curcumin-containing supplements or foods containing high concentrations of curcumin within 14 days prior to dosing;
15 Use of any OTC products within 14 days or within 5 half-lives of the drug, whichever is longer prior to dosing and throughout study;
16 History or presence of significant gastric and/or duodenal ulceration;
17 Use of any recreational drug or history of drug addiction
18 Consumption of xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) within 48.00 hours prior to dosing in each study period and throughout sampling time points;
19 Consumption of grapefruit or its juice within 72.00 hours prior to dosing in each study period and throughout sampling time points;
20 Subject is intolerant to venipuncture.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Maximum measured plasma concentration,The area under the plasma concentration versus time curve from time ‘0’ to the last measurable concentration
The area under the plasma concentration versus time curve from time ‘0’ extrapolated infinity
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
OLNP-18 is a bioavailable curcumin product developed by Olene Life Sciences Pvt.Ltd and this study is to evaluate the bioavailability of test product OLNP-18 in comparison with the reference product. The primary purpose of the study is to evaluate the relative oral bioavailability of the Test product (OLNP-18) against the reference product Standard curcuminoids.