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Two period crossover study comparison of ginger extract capsule 250mg and ginactiv® capsule 250mg of aurea biolabs private limited in healthy adult human subject under fasting conditions.

An open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, two-way crossover, oral comparative bioavailability study of Ginactiv® capsule 250mg and Ginger extract capsule 250mg in healthy, adult, human subjects under fasting conditions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052192
Enrollment
11
Registered
2023-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Ginactiv® Capsule 250mg: test product named as test product Two-Treatment Single-Dose Oral Comparative Bioavailability Study Of Ginactiv® Capsule 250mg washout period of at least 4 da

Sponsors

Aurea Biolabs Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Is and will be available to participate for the entire study period and have willingness to adhere to Protocol requirements as evidenced by the written ICF duly signed by the volunteer. Is a healthy human male subject in the age group between 18 to 45 years (both inclusive) and BMI must be within the range of 18.50 -30.00 Kg/m2 (both inclusive) with minimum body weight 50kg. Has no evidence of any underlying disease during screening, medical history and whose physical examination is performed within 29 days prior to drug administration of Period I. Has screening laboratory values within normal limits or considered by the Investigator to be of no clinical significance. Agreeing not to consume food, drink and condiment containing ginger during the all duration of the study. Does not have alcohol dependence, alcohol abuse or drug abuse (Amphetamines, Cocaine, Tetra Hydro Cannabinoids, Benzodiazepines, Barbiturates and Opioids) within the past one year. Agrees to abstain from consuming xanthine-containing food products or beverages (chocolates, tea, coffee or cola drinks), tobacco containing products (cigarettes, pan, ghutka etc.,) and alcohol containing beverages from 72.00 hours prior to dosing of period I and during the entire study. Agree to abstain from Ginger containing edible or beverage products within 03 days prior to dosing and throughout the study. Is declared eligible to participate in the study by the investigator(s).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
To evaluate comparative bioavailability of Ginactiv® Capsule 250mg By Aurea Biolabs Private Limited, XI/304 A, Kadayiruppu, Kolenchery, Cochin, Kerala and Ginger extract Capsule 250mg Aurea Biolabs Private Limited, XI/304 A, Kadayiruppu, Kolenchery, Cochin, Kerala in healthy, adult, human Male subjects under fasting conditions.Timepoint: The post dose blood samples 05 mL each will be collected at 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 04.00, 06.00, 10.00 and 24.00—

Secondary

MeasureTime frame
To monitor the adverse events and ensure safety of subjects.Timepoint: outcome will be assessed/estimated from 00.25 to 24.00 (ie The post dose blood samples 05 mL each will be collected at 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 04.00, 06.00, 10.00 and 24.00)—

Countries

India

Contacts

Public ContactDr Madan Kartiya MBBS

Micro Therapeutic Research Labs Private Limited

investigator@microtheraps.com9940502533

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026