Healthy VolunteerNCT07141368
Single Oral Dose Comparative Bioavailability Study of Investigational Product in Healthy Human Subjects Under Fasting Conditions.
A study testing Curcumin Dispersome formulation, Non-formulated Curcumin and Benchmark Formulation 1 - Turmipure Gold™ in people with Healthy Volunteer, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial summary
The sponsor has developed new curcuminoid formulations with the expectation of enhanced bioavailability compared to existing benchmark products. This study aims to evaluate the comparative bioavailability and characterize the pharmacokinetic profile of the test formulations in comparison to the reference formulations… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Curcumin Dispersome formulation, Non-formulated Curcumin and Benchmark Formulation 1 - Turmipure Gold™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- 15 Sep 2025to 7 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 9.5.1 Able and willing to participate in the study by complying with the protocol procedures as evidenced by a dated and signed informed consent form 9.5.2 Age greater than equal to 18 less than equal to 45 years. 9.5.3 Willing to consume the study product and donate blood. 9.5.4 BMI from 18.5 to 29.9 kg/m². 9.5.5 Subject with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable limits.
- 9.5.6 Subjects having vital parameters (blood pressure, body temperature, pulse rate and respiratory rate) within acceptable limits.
- 9.5.7 Non-smokers or mild/moderate smokers with not more than 10 bidis/cigarettes/pipes per day, and willing to abstain from smoking or chewing any tobacco containing products at least 72.00 hours prior to check-in and throughout the sampling points.
- 9.5.8 Agreeing not to consume food, drink and condiment containing curcumin (e.g. curry), or other curcuminoids (DMC, BDMC) for the whole duration of the study (36 hours pre-dose to 24 hours post-dose in each period).
- 9.5.9 Good general and mental health in the opinion of the investigator: no clinically significant or relevant abnormalities upon review of medical history or following a physical examination prior to check-in.
- 9.5.10 If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator, such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence Or She is surgically sterile (had a bilateral tubal ligation, bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 06 months).
Who cannot join
- 9.6.1 Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract or may affect absorption of IP and blood forming organ.
- 9.6.2 Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric disease or organ dysfunction.
- 9.6.3 Any major illness or hospitalization within 90 days prior to first admission to the study.
- 9.6.4 Use of any depot injection or an implant of any drug within 3 months prior to check-in and throughout the study.
- 9.6.5 Use of any prescribed medication or OTC (including herbal drugs and vitamin supplements) within 14 days prior to check-in and throughout the study.
- 9.6.6 Use of botanical dietary supplements during the study or within three months prior to check-in.
Show all 23Show fewer
- 9.6.7 Difficulty in swallowing capsules. 9.6.8 History or presence of alcohol abuse in the past one year [Alcohol abuse will be defined as greater than 14 drinks per week (1 drink equal to 360 mL beer, 150 mL wine, or 45 mL hard liquor)].
- 9.6.9 Consumption of alcoholic products within 24.00 hours prior to check-in in each study period and throughout sampling time points.
- 9.6.10 Positive alcohol breath or urine drug of abuse test during check-in on each study period.
- 9.6.11 Consumption of xanthine's or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) within 48.00 hours prior to check-in and throughout sampling time points.
- 9.6.12 Consumption of grapefruit or its juice within 72.00 hours prior to check-in in each period and throughout sampling time points.
- 9.6.13 History of allergy or hypersensitivity intolerance to turmeric or curcumin.
- 9.6.14 Individuals who, in the opinion of the investigator, are unlikely to be able to comply with the study.
- 9.6.15 Irritable bowel syndrome. 9.6.16 Current disease states that are contraindicated with dietary supplementation: chronic diarrhea, constipation or abdominal pain, chronic laxatives use.
- 9.6.17 Pathology which could affect the study results or expose the subject to an additional risk according to the investigator.
- 9.6.18 Recent gastroenteritis or food borne illness such as confirmed food poisoning (less than 1 month).
- 9.6.19 Blood donation within 90 Days prior to the initial visit or intending to donate within the next 90 Days.
- 9.6.20 Low venous capital not allowing blood kinetic sampling. 9.6.21 Known or suspected food allergy, intolerance, or hypersensitivity to any of the study product ingredients and/or of the standard meals (gluten intolerance, celiac disease, etc.) 9.6.22 Chronic drug treatment (for example anticoagulant, antihypertensive medication, thyroid treatment, asthma treatment, anxiolytic, antidepressant, lipid-lowering treatment, corticosteroids, phlebotonic, veino-tonic, drug with impact on blood circulation) excluding oral and local contraceptives.
- 9.6.23 Currently taking (or during the past 3 months) any botanical dietary supplement.
- 9.6.24 History of anorexia nervosa, bulimia, or significant eating disorders according to the investigator.
- 9.6.25 Participation in another clinical trial 90 days prior to check-in period I of this study.
- 9.6.26 Presenting a psychological or linguistic incapability to sign the informed consent.
- 9.6.27 Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 06 months prior to check-in or used hormonal contraceptives within 14 days before check-in 9.6.28 Female volunteer who demonstrates a positive urine pregnancy test at prior to check-in and any time during the study 9.6.29 Each female study volunteer will be screened for urine pregnancy test at screening and at the check-in in each study period. Study volunteer with a positive or inconclusive result will be withdrawn from the study 9.6.30 Female volunteer who is currently breast feeding. 9.6.31 Female study volunteer who is pregnant, breast-feeding or who is likely to become pregnant during the study will not be allowed to participate. Female study volunteer of child bearing potential must either agree to abstain from sexual intercourse or use 2 reliable methods of contraception (e.g. condom, IUD) during the course of the study (first dosing until last blood collection) or she will not be allowed to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Balanced, Four-Treatment, Four-Sequence, Four-Period, Four-way Crossover, Single Oral Dose Comparative Bioavailability Study of Curcumin in Healthy Human Subjects Under Fasting Conditions.
The sponsor has developed new curcuminoid formulations with the expectation of enhanced bioavailability compared to existing benchmark products. This study aims to evaluate the comparative bioavailability and characterize the pharmacokinetic profile of the test formulations in comparison to the reference formulations in healthy adult subjects under fasting conditions.
Read the detailed description
This study is an open-label, randomized, balanced, single oral dose, four-treatment, four-sequence, four-period, four-way cross-over comparative bioavailability trial designed to assess the bioavailability of different curcumin formulations in healthy adult volunteers under fasting conditions. A total of 24 subjects will be enrolled, each receiving four investigational products in a randomized sequence: non-formulated curcumin (90 mg, 1 capsule), Curcumin Dispersome formulation (600 mg; 2 x 300 mg capsules, each containing 90 mg curcumin), Turmipure Gold™ (300 mg, 1 capsule), and Qunol, Turmeric, Curcumin Complex, Extra Strength (1000 mg; 2 x 500 mg capsules). Each product will be administered as a single oral dose with 240 mL of water after at least 10 hours of fasting. Subjects will be housed in the clinical facility for at least 36 hours prior to dosing and remain for at least 24 hours post-dose during each period, with a minimum 7-day washout between periods. Safety will be monitored through clinical examination, vital signs, ECG, and laboratory assessments throughout the study. Blood samples for pharmacokinetic analysis will be collected at 13 time points in each period, and subjects will receive standardized turmeric-free meals and adhere to strict dietary and medication restrictions. The primary objective is to compare the bioavailability of the investigational products, with secondary objectives including the evaluation of safety and tolerability in the study population.
- Conditions
- Healthy Volunteer
- Being tested
- Curcumin Dispersome formulation, Non-formulated Curcumin, Benchmark Formulation 1 - Turmipure Gold™, Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin Dispersome formulationOther
75% BLG (600 mg (2 capsules of 300 mg each, containing 90 mg curcumin per capsule
Non-formulated CurcuminOther
dose: 100 mg, 1 capsule
Benchmark Formulation 1 - Turmipure Gold™Other
recommended daily dose: 300 mg, 1 capsule
Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra StrengthOther
recommended daily dose: 1000 mg, 2 capsules of 500 mg each
| Study group | Role | What they receive |
|---|---|---|
| Curcumin Dispersome formulation | Experimental | 75% BLG (600 mg (2 capsules of 300 mg each, containing 90 mg curcumin per capsule Receives: Other: Curcumin Dispersome formulation |
| Non-formulated Curcumin | Experimental | dose: 100 mg, 1 capsule Receives: Other: Non-formulated Curcumin |
| Benchmark Formulation 1 - Turmipure Gold™ | Active comparator | recommended daily dose: 300 mg, 1 capsule Receives: Other: Benchmark Formulation 1 - Turmipure Gold™ |
| Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strength | Active comparator | recommended daily dose: 1000 mg, 2 capsules of 500 mg each Receives: Other: Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of investigational products when compared with benchmark products, for Comparative Bioavailability Assessment (Cmax, AUC) under Fasting Conditions.
To assess the comparative bioavailability of investigational products versus benchmark products by evaluating pharmacokinetic parameters including maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC), in healthy adult subjects under fasting conditions.
Measured: Pre-dose at -1.00 and 0.00 hours (within 10 minutes prior to dosing), and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00, and 24.00 hours post-dose.
Secondary outcomes (1)
Number of Participants With safety and tolerability of the product after Administration of Curcumin
The safety and tolerability of Curcumin will be evaluated by monitoring and recording, including physical examination findings, clinical laboratory results, vital signs, and participant-reported symptoms, following administration under fasting conditions.
Measured: From pre-dose (-1.00 and 0.00 hours) to 24 hours post-dose (0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00, and 24.00 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start15 Sep 2025
- Primary completion7 Oct 2025
- Study completion7 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An Open Label, Randomized, Balanced, Four-Treatment, Four-Sequence, Four-Period, Four-way cross-over, Single Oral dose comparative
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Sanjay Vaze, MBBS, Principal investigator, Vedic Lifesciences Pvt.Lts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141368
- Sponsor's protocol ID
- 061-25
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Balanced, Four-Treatment, Four-Sequence, Four-Period, Four-way Crossover, Single Oral Dose Comparative Bioavailability Study of Curcumin in Healthy Human Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT07141368
- Acronym / sponsor ID
- 061-25
- Conditions
- Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The sponsor has developed new curcuminoid formulations with the expectation of enhanced bioavailability compared to existing benchmark products. This study aims to evaluate the comparative bioavailability and characterize the pharmacokinetic profile of the test formulations in comparison to the reference formulations in healthy adult subjects under fasting conditions.
Detailed description
This study is an open-label, randomized, balanced, single oral dose, four-treatment, four-sequence, four-period, four-way cross-over comparative bioavailability trial designed to assess the bioavailability of different curcumin formulations in healthy adult volunteers under fasting conditions. A total of 24 subjects will be enrolled, each receiving four investigational products in a randomized sequence: non-formulated curcumin (90 mg, 1 capsule), Curcumin Dispersome formulation (600 mg; 2 x 300 mg capsules, each containing 90 mg curcumin), Turmipure Gold™ (300 mg, 1 capsule), and Qunol, Turmeric, Curcumin Complex, Extra Strength (1000 mg; 2 x 500 mg capsules). Each product will be administered as a single oral dose with 240 mL of water after at least 10 hours of fasting. Subjects will be housed in the clinical facility for at least 36 hours prior to dosing and remain for at least 24 hours post-dose during each period, with a minimum 7-day washout between periods. Safety will be monitored through clinical examination, vital signs, ECG, and laboratory assessments throughout the study. Blood samples for pharmacokinetic analysis will be collected at 13 time points in each period, and subjects will receive standardized turmeric-free meals and adhere to strict dietary and medication restrictions. The primary objective is to compare the bioavailability of the investigational products, with secondary objectives including the evaluation of safety and tolerability in the study population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- An Open Label, Randomized, Balanced, Four-Treatment, Four-Sequence, Four-Period, Four-way cross-over, Single Oral dose comparative
| Arm | Type | Receives |
|---|---|---|
| Curcumin Dispersome formulation | Experimental | Other: Curcumin Dispersome formulation75% BLG (600 mg (2 capsules of 300 mg each, containing 90 mg curcumin per capsule |
| Non-formulated Curcumin | Experimental | Other: Non-formulated Curcumindose: 100 mg, 1 capsule |
| Benchmark Formulation 1 - Turmipure Gold™ | Active comparator | Other: Benchmark Formulation 1 - Turmipure Gold™recommended daily dose: 300 mg, 1 capsule |
| Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strength | Active comparator | Other: Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strengthrecommended daily dose: 1000 mg, 2 capsules of 500 mg each |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 9.5.1 Able and willing to participate in the study by complying with the protocol procedures as evidenced by a dated and signed informed consent form 9.5.2 Age greater than equal to 18 less than equal to 45 years. 9.5.3 Willing to consume the study product and donate blood. 9.5.4 BMI from 18.5 to 29.9 kg/m². 9.5.5 Subject with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable limits.
- 9.5.6 Subjects having vital parameters (blood pressure, body temperature, pulse rate and respiratory rate) within acceptable limits.
- 9.5.7 Non-smokers or mild/moderate smokers with not more than 10 bidis/cigarettes/pipes per day, and willing to abstain from smoking or chewing any tobacco containing products at least 72.00 hours prior to check-in and throughout the sampling points.
- 9.5.8 Agreeing not to consume food, drink and condiment containing curcumin (e.g. curry), or other curcuminoids (DMC, BDMC) for the whole duration of the study (36 hours pre-dose to 24 hours post-dose in each period).
- 9.5.9 Good general and mental health in the opinion of the investigator: no clinically significant or relevant abnormalities upon review of medical history or following a physical examination prior to check-in.
Key exclusion criteria (23 listed)
- 9.6.1 Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract or may affect absorption of IP and blood forming organ.
- 9.6.2 Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric disease or organ dysfunction.
- 9.6.3 Any major illness or hospitalization within 90 days prior to first admission to the study.
- 9.6.4 Use of any depot injection or an implant of any drug within 3 months prior to check-in and throughout the study.
- 9.6.5 Use of any prescribed medication or OTC (including herbal drugs and vitamin supplements) within 14 days prior to check-in and throughout the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin Dispersome formulation75% BLG (600 mg (2 capsules of 300 mg each, containing 90 mg curcumin per capsule | Other | Curcumin Dispersome formulation |
| Non-formulated Curcumindose: 100 mg, 1 capsule | Other | Non-formulated Curcumin |
| Benchmark Formulation 1 - Turmipure Gold™recommended daily dose: 300 mg, 1 capsule | Other | Benchmark Formulation 1 - Turmipure Gold™ |
| Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strengthrecommended daily dose: 1000 mg, 2 capsules of 500 mg each | Other | Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strength |
Primary outcome
Plasma Concentration of investigational products when compared with benchmark products, for Comparative Bioavailability Assessment (Cmax, AUC) under Fasting Conditions.
Time frame: Pre-dose at -1.00 and 0.00 hours (within 10 minutes prior to dosing), and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00, and 24.00 hours post-dose.
To assess the comparative bioavailability of investigational products versus benchmark products by evaluating pharmacokinetic parameters including maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC), in healthy adult subjects under fasting conditions.
1 secondary outcome
Number of Participants With safety and tolerability of the product after Administration of Curcumin
Time frame: From pre-dose (-1.00 and 0.00 hours) to 24 hours post-dose (0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00, and 24.00 hours).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Sanjay Vaze, MBBS principal investigator
Vedic Lifesciences Pvt.Lts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin Dispersome formulation, Non-formulated Curcumin and Benchmark Formulation 1 - Turmipure Gold™ in people with Healthy Volunteer, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of investigational products when compared with benchmark products, for Comparative Bioavailability Assessment (Cmax, AUC) under Fasting Conditions. (time frame: Pre-dose at -1.00 and 0.00 hours (within 10 minutes prior to dosing), and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 4.00, 6.00, 8.00, 12.00, and 24.00 hours post-dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.