| CTRI Number |
CTRI/2022/10/046501 [Registered on: 14/10/2022] Trial Registered Prospectively |
| Last Modified On: |
10/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial study to determine the oral bio-availability of TurmXtra 60N capsules. |
|
Scientific Title of Study
|
An Open label, randomized, balanced, two treatment, two sequence, two period, crossover, oral dose comparative pharmacokinetic study of TurmXtra 60N Capsule 250 mg (containing 150 mg of curcuminoids from Water Dispersible Turmeric Extract , 1 x 250 mg) (T) manufactured by Nutriventia Limited. with that of Turmeric extract Capsules (containing 500 mg of C3 Complex curcuminoids and 5 mg bioperine,3 x 500 mg, one capsule 6 hourly) (R) manufactured by Sami-Sabinsa Group Limited, India in normal, healthy, adult, human subjects under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 22-ENGV-051 version 01 dated 17 Sep 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kamlesh Sanghani |
| Designation |
Principal Investigator |
| Affiliation |
MBBS |
| Address |
Enem Nostrum Remedies Pvt. Ltd. Plot No 35, Ancillary Indl. Plot, Govandi, Mumbai-400043, India
Enem Nostrum Remedies Pvt. Ltd. Plot No 35, Ancillary Indl. Plot, Govandi, Mumbai-400043, India
Mumbai
MAHARASHTRA
400043
India |
| Phone |
91-22-25488200 |
| Fax |
|
| Email |
Kamlesh.Sanghani@enemcro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamlesh Sanghani |
| Designation |
Principal Investigator |
| Affiliation |
MBBS |
| Address |
Enem Nostrum Remedies Pvt. Ltd. Plot No 35, Ancillary Indl. Plot, Govandi, Mumbai-400043, India
Enem Nostrum Remedies Pvt. Ltd. Plot No 35, Ancillary Indl. Plot, Govandi, Mumbai-400043, India
Mumbai
MAHARASHTRA
400043
India |
| Phone |
91-22-25488200 |
| Fax |
|
| Email |
Kamlesh.Sanghani@enemcro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamlesh Sanghani |
| Designation |
Principal Investigator |
| Affiliation |
MBBS |
| Address |
Enem Nostrum Remedies Pvt. Ltd. Plot No 35, Ancillary Indl. Plot, Govandi, Mumbai-400043, India
Enem Nostrum Remedies Pvt. Ltd. Plot No 35, Ancillary Indl. Plot, Govandi, Mumbai-400043, India
Mumbai
MAHARASHTRA
400043
India |
| Phone |
91-22-25488200 |
| Fax |
|
| Email |
Kamlesh.Sanghani@enemcro.com |
|
|
Source of Monetary or Material Support
|
| Nutriventia Limited, Unit 703, 704, 7th floor, Hubtown Solaris, N.S.Phadke Marg, Andheri |
|
|
Primary Sponsor
|
| Name |
Nutriventia limited |
| Address |
Nutriventia limited, Unit 703, 704, 7th floor, Hubtown Solaris, N.S.Phadke Marg, Andheri |
| Type of Sponsor |
Other [Nutraceutical] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kamlesh Sanghani |
Enem Nostrum Remedies Pvt. Ltd |
Enem Nostrum Remedies Pvt. Ltd., Plot No-35, Ancillary Indl. Plot, Govandi, Mumbai-400043, India.
Mumbai
MAHARASHTRA |
91-22-25488200
Kamlesh.Sanghani@enemcro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Care Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
under fasting conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Turmeric extract Capsules |
Turmeric extract Capsules (containing 500 mg of curcuminoids and 5 mg piperine) |
| Intervention |
TurmXtra 60N Capsules |
TurmXtra 60N Capsule 250 mg (containing 150 mg of curcuminoids from Water Dispersible Turmeric Extract) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Male Subjects aged between 18 and 45 years (both inclusive). Subject’s weight within normal range according to normal values for Body Mass Index (18.50 to 29.99 kg/m2) (both inclusive) with minimum of 50 kg weight. Subjects with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable limits. Subject having vital parameters (blood pressure, body temperature, pulse rate and respiratory rate) within acceptable limits.Subjects having clinically acceptable 12-lead electrocardiogram (ECG). Subjects having clinically acceptable chest X-Ray (PA view) whose X-Ray was taken not more than 180 days prior to the dosing of Period 01. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine). Subjects having negative urine alcohol test. Subjects willing to adhere to the protocol requirements and to provide written informed consent. Subjects willing to follow diets free of turmeric and black pepper and any spice mixtures containing turmeric and / or black pepper starting at least 7 days before period I check in till end of period II, including entire study period. |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to study drug or related class of drugs or to the inactive ingredients of the test and reference formulation. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological disease or disorder. Use of any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month prior to dosing of period 01. History or presence of drug abuse in the past one year. History or presence of significant smoking (more than 10 cigarettes or beedis/day) or could not abstain from smoking during study. History or presence of alcohol abuse in the past one year Alcohol abuse will be defined as >14 drinks per week (1 drink - 360 mL beer, 150 mL wine, or 45 mL hard liquor). History or presence of asthma, urticaria or other significant allergic reactions. History or presence of significant gastric and/or duodenal ulceration. Difficulty with donating blood. Difficulty in swallowing solids dosage forms like tablets or capsules. Use of any prescribed medication or OTC medication including vitamins and herbal remedies during last 14 days prior to dosing in period 01. Major illness or hospitalization within past 3 months. Volunteer who have donated 1 unit blood (≥ 300 mL) or participated in a clinical study involving blood sampling within 90 days prior to the first dose of the study drug. Consumption of grapefruit juice within 72 hours prior to dosing and xanthine-containing products, tobacco containing products or any alcoholic products within 48 hours prior to dosing. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C. History or presence of significant easy bruising or bleeding. History or presence of significant recent trauma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To test bioavailability between test product and reference product |
PK Samples will be collected at -12.00, -02.00, 00.00, 00.50, 01.00, 02.00, 03.00, 04.00; 05.00, 06.50, 07.00, 08.00, 09.00, 10.00, 11.00, 12.50, 13.00, 14.00, 16.00, 18.00, 20.00 and 24.00 hours following IP administration in each period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of test product in comparison to reference product |
-48.00, -24.00, -2.00, 3.00, 6.00, 11.00, 24.00 hours in each period and Post Study Evaluation |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is conducted to assess relative absorption and relative bioavailability between test product and reference product in 16 healthy, adult, male, human subjects under fasting conditions housed at least 60.00 hrs pre-dose to 24.00 hrs post-dose in a crossover study with 7 days washout period. The Parameters tested in this study are as follows : Primary PK parameters: Cmax, AUC0-t, AUC0-12, AUC0-24 and AUC0-inf. Secondary PK parameters: Tmax, t1/2, Kel and AUCExtrapolated |