None listed
Conditions
Interventions
Intervention1: Curcumin: Dose - 10 mg orally soluble tablets
frequency route of administration - oral
Duration of therapy - Single dose
Control Intervention1: Curcunex G: Dose - 5mg
frequency route o
Sponsors
KMS Health Center Pvt Ltd
KMS Health Center Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Healthy, adult, human male volunteers of age between 18-45 years
Exclusion criteria
Exclusion criteria: 1. Evidence of allergy or known hypersensitivity to Curcumin and its inactive ingredients. 2. Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse and recently overcome or active existing tinnitus. 3. Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. 4. Any major illness in the last three months or any significant ongoing chronic medical illness. 5. Any disease or condition which might compromise the hemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system. 6. History of drug abuse within 03 months (including benzodiazepines, opioids, cocaine, barbiturates, THC and amphetamine etc.). 7. History of alcohol addiction or abuse. 8. History of difficulty in swallowing. 9. History of difficulty in accessibility of veins. 10. Any blood donation / excess blood loss within 90 days of check-in. 11. Subject who had participated in any other study within the 90 days of study check-in. 12. Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study. 13. Consumption of alcohol and its products, grapefruit and/ or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study. 14. Use of any prescribed medication within 14 days and any over the counter medicinal products, herbal medications, etc. within 07 days prior to study check in and throughout the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To ensure the safety and tolerability of the study subjects.Timepoint: 00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00 and 24.00 hrs | — |
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the Relative Bioavailability of Curcumin 10 mg Orally Soluble Tablet Manufactured by KMS Health Center Pvt. Ltd., East Tambaram, Selaiyur, Chennai and Curcunex G 5 mg Manufactured by Yeus Lifescience Pvt Ltd, A-10, Art Gold House, LBS Marg, Mumbai - 400 070 in Healthy, Adult, Human, Male Subjects Under Fasting Conditions. Timepoint: 00.25, 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00 and 24.00 hrs | — |
Countries
India
Contacts
Public ContactDr Reenee Rajan
Micro Therapeutic Research Labs Pvt. Ltd.
Outcome results
None listed