A clinical trial to assess the bioavailability and safety of nano-atropine sulfate by dry powder inhalation in healthy human volunteers for nerve gas poisoning
Phase 1
Completed
- Registration Number
- CTRI/2010/091/001350
- Lead Sponsor
- Defence R&D Organisation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
1. Male human volunteers, 18-65 years of age, body weight of 50-70kg.
2. May include mild smokers who are willing to abstain smoking on the day of test
Exclusion Criteria
1. Volunteers who are unwilling to give informed consent.
2. Volunteers taking any medication or having URI/lung infection at time of study.
3. Volunteers with significant dyspnea or cough due to any cause.
4. Volunteers having any contraindications like increased intraocular pressure (IOP), lung disease, unstable cardiac rhythm, tachycardia etc
5. Volunteers who have compromised lung function due to any cause
6. Volunteers who have any medical condition which in the judgment of the investigator may render them in appropriate for participation in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate the effect of treatment with nano-atropine sulfate (6 mg) by DPI<br>2. To evaluate the increase in bioavailability if any of atropine sulfate in comparison to intramuscularly administered atropine sulfate<br>Timepoint: NI
- Secondary Outcome Measures
Name Time Method 1. To evaluate the effect of treatment with study medication on heart rate (HR), salivation, papillary diameter and eye dryness<br>2. To evaluate the safety and tolerability of study medication. <br>3. To evaluate the physicians? and volunteers? overall assessment of the effectiveness and tolerability of the study medication<br>Timepoint: NI