A clinical trial to assess the bioavailability and safety of atropine sulfate injected by sublingual submucosal injection in healthy human volunteers for nerve gas poisoning
Phase 1
Completed
- Registration Number
- CTRI/2010/091/001352
- 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, 18-65 yrs of age, body weight of 50-70kg.
Exclusion Criteria
1. Volunteers who are unwilling to give informed consent.
2. Volunteers taking any medication.
3. Volunteers having any contraindications like increased intraocular pressure (IOP), ENT problem, unstable cardiac rhythm, tachycardia etc
4. Volunteers on cholinergic/anticholinergic or any treatment likely to affect local vascularity / atropinization observation.
5. Volunteers having apthous ulcers, oral infection / fibrosis
6. Chronic use of pan masala containing nicotine, chronic smoker
7. 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 (2MG) by sublingual submucosal injection route<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