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To estimate the Bioavailability of CANSSUFIVE® Nuvastatic in healthy adult Male Human Subjects.

For SAD study: An open label, randomized, single period, single ascending dose to establish the bioavailability parameters of the formulation, CANSSUFIVE® Nuvastatic (C5OSEW5050ESA), composed of standardized extract of Orthosiphon stamineus in 48 healthy, adult, male human subjects under fasting conditions. For MAD study: An open label, randomized, single period, multiple ascending dose to establish the bioavailability parameters of the formulation, CANSSUFIVE® Nuvastatic (C5OSEW5050ESA), composed of standardized extract of Orthosiphon stamineus in 32 healthy, adult, male human subjects under fasting conditions. For cross over study: An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose oral bioequivalence study of formulation, CANSSUFIVE® Nuvastatic (C5OSEW5050ESA), composed of standardized extract of Orthosiphon stamineus in tablet and powder forms in 24 healthy, adult, male human subjects under fasting conditions. - NRPL-056-CANS-16

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009645
Enrollment
104
Registered
2017-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: CANSSUFIVE®-Nuvastatic: For subjects who are dosed under SAD design, 48 subjects will be divided into 6 cohorts of 08 subjects each. Cohort 01 will receive 250 mg of CANSSUFIVE® in po

Sponsors

Natureceuticals Sdn Bhd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age- 18-55 years 2. Weight within the BMI of 18-28 kg/m2 3. Have normal histories, physical examinations, and routine laboratory test results 4. Able to complete the clinical trial and follow-up 5. Capable of providing Informed written consent

Exclusion criteria

Exclusion criteria: 1. Women 2. Age 55 years 3. Have taken any medication within 1 week of initiation of the trial 4. Hepatitis B. Hepatitis C and HIV positive 5. Inability to give informed consent 6. The results of the laboratory tests are not within the limits considered normal and deemed clinically significant by the research physician. 7. Participation in other experimental drug studies within 4 weeks of this study 8. A history of drug and/or alcohol use, or the ingestion of alcohol within 24 hours of the study 9. Donation of plasma (500 ml) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows a) 50 ml to 300 ml of whole blood within 30 days. b) 301 ml to 500 ml of whole blood within 45 days, or c) more than 500 ml of whole blood within 90 days prior to drug administration Smokes more than 10 cigarettes/ cigars/ beedisâ?? a day 10. Hospitalised for any reason within 4 weeks of the study 11. A history of hepatic, cardiac, renal, pulmonary,haematological,gastrointestinal, neurological or psychiatric disease 12. A history of allergy, or any adverse event to any medication

Design outcomes

Primary

MeasureTime frame
AUC0-t , AUCï?¥, Cmax, Tmax, CL/F, V/F, t1/2 ,Kel, AUC0-24Timepoint: 00.17, 00.33, 00.50, 00.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hours—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactAnil Kumar BH

Notrox Research Pvt Ltd

anilkumar@notroxresearch.com080-26643007

Outcome results

None listed

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