2 PERIOD FASTING STUDY IN HEALTHY, NORMAL, ADULT, HUMAN MALE, RANDOMLY DOSED IN EACH PERIOD WITH OLNP-18 OR STANDARD CURCUMINOIDS

Completed

Conditions: Healthy, normal, adult, human male

Registration Number: CTRI/2019/07/020467

Lead Sponsor: Olene Life Sciences Private Limited

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 18

Inclusion Criteria

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 Â± 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.

Exclusion Criteria

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.
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.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum measured plasma concentration,The area under the plasma concentration versus time curve from time â€˜0â€™ to the last measurable concentration	15 time points \| 00.25, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 06.00, 08.00, 12.00, 00.25, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours post dose
The area under the plasma concentration versus time curve from time â€˜0â€™ extrapolated infinity	15 time points \| 00.25, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 06.00, 08.00, 12.00, 00.25, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours post dose

Secondary Outcome Measures

Name	Time	Method
Tmax, kel and tÂ½.	00.25, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours post dose

Trial Locations

Locations (1): Vimta Labs Ltd.
🇮🇳
Hyderabad, TELANGANA, India
Vimta Labs Ltd.
🇮🇳Hyderabad, TELANGANA, India
Dr M Missamma
Principal investigator
40-27264141
jeevadaya@vimta.com