A study to find the difference in bioavailability of 3 different ingredients through FenuMAT delivery system and its comparison with natural existing forms.
Not Applicable
Completed
- Registration Number
- CTRI/2018/03/012753
- Lead Sponsor
- Akay Flavours and Aromatics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
1. Healthy male and female volunteers
2. Subjects who are currnetly not under
longterm medications.
3. Subjects who are willing to provide a written informed consent and comply with the protocol requirements.
Exclusion Criteria
1. Subject who received any ingredients of formulations under study in last 48 hours.
2. Known Hypersensitivity to Herbal formulations.
3. Subjects who have particpated in any clinical study in within last one month.
4. pregnant or lactating women.
5. Any other condition that in the opinion of the investigator that does not justify the subjectâ??s participation in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUC,AUMCTimepoint: 0.0,0.5,1.0,1.5,2.0.2.5,3.0, 4.0,6.0,8,12,24.0 Hours
- Secondary Outcome Measures
Name Time Method Adeverse events and Safety assessmentsTimepoint: 0.0,0.5,1.0,1.5,2.0.2.5,3.0, 4.0,6.0,8,12,24.0 Hours