A clinical trial to assess the efficacy and safety of atropine sulfate by inhalation in healthy human volunteers for nerve gas poisoning
Phase 1
Completed
- Registration Number
- CTRI/2010/091/001351
- 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
Male healthy human volunteers, 18-65 years of age, body weight of 50-70kg
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 1% atropine sulfate in 30% ethyl alcohol saline (15 mg) through ITAD nebulization, estimated to give 2 mg for systemic absorption through lungs.<br><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) and atropinization signs/symptoms<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