A clinical trial to assess the bioavailability and safety of atropine sulfate by intranasal drops in healthy human volunteers for nerve gas poisoning
Phase 1
Completed
- Registration Number
- CTRI/2010/091/001347
- 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 healthy human volunteers, above 18-65 years of age, body weight of 50-70kg.
2. Clear wide nasal passage with minimal hair
Exclusion Criteria
1. Volunteers who are unwilling to give informed consent.
2. Volunteers taking any medication.
3. Volunteers having any nasal infection or disorder like adenoids, significant DNS, significant hair growth.
4. Volunteers having any contraindications like increased intraocular pressure (IOP), lung disease, unstable cardiac rhythm, tachycardia etc.
5. Volunteers who have had an upper respiratory tract or acute sinus infection
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 atropine sulfate (10MG/ML) intranasal (single dose 0.6 ML) dose<br>2. To evaluate the increase in bioavailability, if any, of intra-nasally administered 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 pupil<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