A clinical study to assess safety, tolerability and pharmacokinetics of curcumin and biocurcumax administered with and without a fixed dose of artesunate in healthy adult male volunteers.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

Subjects to be enrolled in this trial must fulfil all of these criteria:

?Sex: male

?Age: 18-45 yr old, both inclusive

?Be neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases

?Vital Signs: 90 SBP140 mmHg, DBP > 90 mmHg, 60 HR 90

?Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; and to comply with the requirements of the entire study

?Informed Consent: signed written informed consent prior to inclusion in the study

Exclusion Criteria

Subjects meeting any of these criteria will not be enrolled in the study:
?History of hypersensitivity and / or intolerance to artesunate, curcumin or biocurcumax or any other related compounds.
Subjects meeting any of these criteria will not be enrolled in the study:
?History of hypersensitivity and / or intolerance to artesunate, curcumin or biocurcumax or any other related compounds.
Subjects meeting any of these criteria will not be enrolled in the study:
?History of hypersensitivity and / or intolerance to artesunate, curcumin or biocurcumax or any other related compounds.
?History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study.
?ECG (12 leads): clinically relevant abnormalities; QTc interval > 450 msec.
?Clinically abnormal Chest X-ray.
?Physical findings: clinically relevant abnormal physical findings (including body temperature) suggesting underlying pathologies or those which could interfere with the objectives of the study.
?Gastrointestinal disorders likely to influence drug absorption including acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea, heart burn), preceding one week to admission.
? Presence of values, which are clinically significantly different from normal reference ranges (as defined in Appendix II and III) for hemoglobin, hematocrit, total white blood cells count, differential WBC count or platelet count.
?Presence of values which are significantly different from normal reference ranges ( as defined in Appendix III and IV) and/or judged clinically significant for blood urea nitrogen, serum creatinine, uric acid, sodium, potassium, alkaline phosphatase, aspartate amino transferase (AST), alanine amino transferase (ALT), total bilirubin, total protein, sodium , potassium or plasma glucose.
?Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose (positive) or proteins (positive).
? Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
?Positive for urinary screen testing of drugs of abuse (Opiates, cannabinoids, barbiturates, amphetamines, cocaine, benzodiazepines.).
? Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
?Diseases: relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine, neurological or gastrointestinal diseases. History of depression, psychosis, schizophrenia or any other severe psychiatric diseases, or epilepsy, or any other illness that may interfere with the aim of the study.
History of any significant illness in the 4 weeks preceding the screening
?Medications: history of any antimalarial treatment in the previous 3 months, other medications including over the counter medications (OTC) during the 4 weeks period prior to the onset of the study.
?Investigational drug trials: participation in the evaluation of any drug including artesunate and curcumin and/or biocurcumax (curcumin dissolved in turmeric oil) in the 3 months prior to the start of the study
?Blood donation: subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months
?History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit eq

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of curcumin and biocurcumax will be assessed after single and ascending multiple doses when administered alone or in combination with artesunate,.on the basis of AEs, vital signs (BP, pulse rate, and body temperature), ECG, and clinical laboratory resultsTimepoint: as per the study protocol

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of single dose of curcumin and biocurcumax assessed on Day 1 in the absence of artesunate Pharmacokinetics of single dose of artesunate 200 mg assessed on Day 1 in the absence of curcumin and biocurcumax Assess drug-drug interaction by comparing pharmacokinetic profile of each drug on Day 1 with the corresponding one of Day 3. Assess effect of multiple dosing on pharmacokinetics of each drug by comparing profiles of Day 3 with corresponding ones of Day 5. Pharmacokinetics parameters: Cmax, Tmax, T1/2, AUC0-t, AUC0-&#61605;, CL/F, Vd/Fs and accumulation of curcumin or biocurcumax (curcumin dissolved in turmeric oil) alone and with artesunate after multiple dose at three dose levelsTimepoint: As per the study protocol