Single Oral Dose Comparative Bioavailability Study of Investigational Product in Healthy Human Subjects Under Fasting Conditions.

NCT07141368 | Not Yet Recruiting

• 1 other identifier: 061-25
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 in healthy adult subjects under fasting conditions.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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).

Study Arms (4)

Curcumin Dispersome formulation

EXPERIMENTAL

75% BLG (600 mg (2 capsules of 300 mg each, containing 90 mg curcumin per capsule

Other: Curcumin Dispersome formulation

Non-formulated Curcumin

EXPERIMENTAL

dose: 90 mg, 1 capsule

Other: Non-formulated Curcumin

Benchmark Formulation 1 - Turmipure Gold™

ACTIVE COMPARATOR

recommended daily dose: 300 mg, 1 capsule

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

Other: Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strength

Interventions

Curcumin Dispersome formulation OTHER

75% BLG (600 mg (2 capsules of 300 mg each, containing 90 mg curcumin per capsule

Curcumin Dispersome formulation

Non-formulated Curcumin OTHER

dose: 90 mg, 1 capsule

Non-formulated Curcumin

Benchmark Formulation 1 - Turmipure Gold™ OTHER

recommended daily dose: 300 mg, 1 capsule

Benchmark Formulation 1 - Turmipure Gold™

Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strength OTHER

recommended daily dose: 1000 mg, 2 capsules of 500 mg each

Benchmark Formulation 2 - Qunol, Turmeric, Curcumin Complex, Extra Strength

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subjects having vital parameters (blood pressure, body temperature, pulse rate and respiratory rate) within acceptable limits.
• 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.
• 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).
• 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.
• 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).

You may not qualify if:

• 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.
• 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.
• Any major illness or hospitalization within 90 days prior to first admission to the study.
• Use of any depot injection or an implant of any drug within 3 months prior to check-in and throughout the study.
• Use of any prescribed medication or OTC (including herbal drugs and vitamin supplements) within 14 days prior to check-in and throughout the study.
• Use of botanical dietary supplements during the study or within three months prior to check-in.
• Difficulty in swallowing capsules. 9.6.8 History or presence of alcohol abuse in the past one year \[Alcohol abuse will be defined as greater than 14 drinks per week (1 drink equal to 360 mL beer, 150 mL wine, or 45 mL hard liquor)\].
• Consumption of alcoholic products within 24.00 hours prior to check-in in each study period and throughout sampling time points.
• Positive alcohol breath or urine drug of abuse test during check-in on each study period.
• 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.
• Consumption of grapefruit or its juice within 72.00 hours prior to check-in in each period and throughout sampling time points.
• History of allergy or hypersensitivity intolerance to turmeric or curcumin.
• Individuals who, in the opinion of the investigator, are unlikely to be able to comply with the study.
• Irritable bowel syndrome. 9.6.16 Current disease states that are contraindicated with dietary supplementation: chronic diarrhea, constipation or abdominal pain, chronic laxatives use.
• Pathology which could affect the study results or expose the subject to an additional risk according to the investigator.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (1)

IndiGlobal Labs Pvt. Ltd

Hyderabad, Telangana, 500051, India

Location

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Dr. Sanjay Vaze, MBBS

  Vedic Lifesciences Pvt.Lts

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Sanjay Vaze, MBBS

CONTACT

8655670964; sanjay.v@vediclifesciences.com

Pooja Gorule

CONTACT

8655728947; pooja.g@vediclifesciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An Open Label, Randomized, Balanced, Four-Treatment, Four-Sequence, Four-Period, Four-way cross-over, Single Oral dose comparative

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 26, 2025
• Study Start: September 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)