A clinical trial to assess the bioavailability and safety of atropine sulfate by intranasal drops in healthy human volunteers for nerve gas poisoning

An open labeled, non-comparative, single centre study to assess the bioavailability and safety of atropine sulfate by intranasal drops in healthy human volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001347

Enrollment

Registered

2010-11-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 1% Atropine sulfate intranasal drops (10MG/ML): Dose: 0.6ML (6MG) of 1% Atropine sulfate (10MG/ML) intranasal drops to be given in the nostrils once

Duration of protocol therapy: 1 day Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. To evaluate the effect of treatment with atropine sulfate (10MG/ML) intranasal (single dose 0.6 ML) dose 2. To evaluate the increase in bioavailability, if any, of intra-nasally administered atropine sulfate in comparison to intramuscularly administered atropine sulfate Timepoint: NIL	—

Secondary

Measure	Time frame
1. To evaluate the effect of treatment with study medication on heart rate (HR) and pupil 2. To evaluate the safety and tolerability of study medication 3. To evaluate the physicians and volunteers overall assessment of the effectiveness and tolerability of the study medication Timepoint: NIL	—

Countries

India

Contacts

Public ContactAseem Bhatnagar

Institute of Nuclear Medicine & Allied Sciences, Defence R&D Organisation, Ministry of Defence

assem_bhatnagar@indiatimes.com011-23905172

Outcome results