None listed
Conditions
Interventions
Intervention1: ICB-014-A002: Oral herbal Capsule Formulation
Intervention2: ICB-014-A002 Oral Capsule Formulation: For Single dose escalation study:
Route of administration: Oral.
Total 5 dose level
Sponsors
Indian Institute of Integrative Medicine Council of Scientific Industrial Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult volunteers within age group of 18-55 years. 2. BMI in the range of 18.50 â?? 24.90 kg/m2 (both inclusive). 3. Volunteers with an abnormal clinical chemistry, hematology or urinalysis results that is considered clinically significant by the investigator or the sponsor. 4. Free of any acute/chronic illness and should not be on treatment for any prior illness. 5. Non-smokers or non-alcoholic. 6. Volunteer must be willing to provide written informed consent and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Volunteer incapable of understanding the informed consent process / procedure. 2. Volunteer who have taken a PPI or a H2 blocker or prokinetic agent or any other gastroprotective agent within seven days of screening 3. Volunteer with known history of any clinically significant medical diseases, hematology, biochemistry or urine analysis will be excluded from the study unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study. 4. Volunteer who have taken any enzymes modifying drugs within the past four weeks prior to start of clinical study 5. Volunteer who have taken any prescribed medications beginning two weeks prior to and OTC medications beginning one week prior to first dosing of study. 6. Investigations with blood samples of the volunteer shows presence of disease marker of HIV 1 and 2, Hepatitis B & C viruses. 7. Positive test for urinary screen testing of drugs of abuse. 8. Volunteer found positive for alcohol breath test. 9. Xanthine-containing food or beverages (tea, coffee, chocolates, soft drinks like cola etc.) within 24 hours prior to the dosing or alcoholic products consumption within 48 hours prior to the dosing. 10. Volunteer who have consumed â??Grape fruitâ?? or its juice within 72 hours prior to dosing of each period. 11. Female volunteers who are found positive in Urinary Pregnancy Test or are lactating. 12. Female volunteers who are using any type of hormonal contraceptives. 13. Volunteer who participated in any other clinical investigation using experimental drug or had bleed more than 300 ml in the past 3 months. 14. Any condition, including laboratory abnormalities, that in the opinion of investigator places the volunteer at an unacceptable risk or deems the volunteer not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of maximum tolerated dose (MTD) by evaluating safety and tolerability of ICB-014-A002.Timepoint: The end-points for the primary objective evaluation are: Frequency and severity of serious adverse events for single dose study. [Time frame: till 4th days post-dose] Frequency and severity of serious adverse events for multiple dose study. [Time frame: till 4th days post-dose] | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of adverse events in single and multiple dose studyTimepoint: Time frame: till 4th days post-last dose;To assess the single dose oral pharmacokinetics (PK) under fasting condition.Timepoint: Time frame: till 24.0 hours post-last dose;To evaluate changes in pharmacokinetic profile with incremental doses of ICB-014-A002. Pharmacokinetic parameters: Cmax, AUC0-t, AUC0-inf, Tmax, t1/2, Kel, Vd, CL/F.Timepoint: Time frame: till 24.0 hour post-dose | — |
Countries
India
Contacts
Public ContactDr Sanjay Patel
Cadila Pharmaceuticals Limited
Outcome results
None listed