A programme to develop a skin patch containing two medicines (physostigmine and hyoscine), study 5: Assessment of blood levels of the two medicines and any associated symptoms in healthy male participants

INTERVENTION: Generic drug name‐ physostigmine and hyoscine (transdermal patch) Dosage ‐ period 1: a single 72 hour application of active 25cm2 patch formulation F‐11. Dosage – period 2: three consecutive 72 hour applications of active or placebo 25cm2 patch formulation F‐11. The safety and tolerability of single application of physostigmine/hyoscine transdermal patches was assessed by monitoring vital signs, ECG, ocular function (near point), patch application site assessment, using digital photography. Tests were performed at intervals for up to Day 14 in period 1 and Day 20 in period 2. CONDITION: Potential risk of poisoning by nerve agent ; Injury, Occupational Diseases, Poisoning PRIMARY OUTCOME: ; Safety and tolerability of the drug assessed by monitoring vital signs, ECG, ocular function (near point), patch application site assessment, using digital photography. Tests were performed at intervals for up to Day 14 in period 1 and Day 20 in period 2; SECONDARY OUTCOME: ; 1. Pharmacokinetic (PK) and pharmacodynamic (PD) profiles measured at regular time points at pre‐dose and up to 96 hours after patch application; 1.1. Physostigmine and hyoscine plasma measured by liquid chromatography‐tandem mass spectrometry (LC‐MS‐MS) method; 1.2. Acetylcholinesterase levels measured at baseline, pre‐dose, and intervals up to 96 hours after patch application. The method was validated spectrophotometric method; INCLUSION CRITERIA: 1. Ability to give written informed consent prior to study participation 2. Healthy Caucasian male participants aged between 18 and 45 years (inclusive) 3. Body Mass Index (BMI) within the range of = 21 and = 30 kg/m2 4. Vital signs within the following ranges: 4.1. Pulse rate 40‐90 bpm 4.2. Systolic blood pressure 90‐140 mmHg 4.3. Diastolic blood pressure 50‐90 mmHg 5. Ability to communicate well with the Investigator and to comply with the requirements of the study.