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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001352

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: Atropine sulfate sublingual submucosal injection (2 mg). Commercial preparation shall be used.: Dose: 2 MG atropine sulphate to be given sublingually as a single dose

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male healthy human volunteers, 18-65 yrs of age, body weight of 50-70kg.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. To evaluate the effect of treatment with atropine sulfate (2MG) by sublingual submucosal injection route 2. To evaluate the increase in bioavailability, if any, of 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), salivation, papillary diameter and eye dryness 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