A programme to develop a skin patch containing two medicines (physostigmine and hyoscine), Study 3: Assessment of blood levels of the two medicines and any associated symptoms in healthy male participants wearing four prototype skin patches.

A Two-part Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Applications of Four Transdermal Patch Formulations of Hyoscine and Physostigmine in Healthy Male Participants

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16859029

Enrollment

Registered

2019-09-19

Start date

2005-10-12

Completion date

Unknown

Last updated

2019-10-29

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

Conditions

Potential risk of poisoning by nerve agent Injury, Occupational Diseases, Poisoning

Interventions

(i) Generic drug name- physostigmine and hyoscine (transdermal patch) (ii) Dosage - In the study 4 patch formulations were tested. Period one: Method

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: At screening for period 1: 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. Baseline (Period 2): 1. Successful completion of Part 1. 2. Randomisation to take part in Part 2. 3. Willing and able to continue in the study.

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of drugs tested was assessed by monitoring vital signs, ECG, near point ocular function and patch application site assessment using digital photography. In period 1 these parameters were measured at baseline and at pre-determined intervals up to 84 hours after patch application, prior to discharge on day 5 and at follow up. In period 2 they were measured at these times and also at additional time points up to follow up at Day 42 after the first patch application	—

Measure

Time frame

Safety and tolerability of drugs tested was assessed by monitoring vital signs, ECG, near point ocular function and patch application site assessment using digital photography. In period 1 these parameters were measured at baseline and at pre-determined intervals up to 84 hours after patch application, prior to discharge on day 5 and at follow up. In period 2 they were measured at these times and also at additional time points up to follow up at Day 42 after the first patch application

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Secondary

Measure	Time frame
1. Pharmacokinetic measures: Plasma concentration of physostigmine and hyoscine tested at following intervals. Period 1: pre-dose and at intervals up to 96 hrs after the patch application. Period 2: pre-dose and at intervals up to 240 hours after application of the first patch. (test method for PK measures was liquid chromatography tandem mass spectrometry (LC-MS-MS) method). 2. Pharmacodynamic measures: Blood measurement of red cell acetylcholinesterase (AChE) activity tested at the following intervals. Period 1: pre-dose and at intervals up to 96 hrs after the patch application. Period 2: pre-dose and at intervals up to 240 hours after application of the first patch. (test method for PK measures was validated spectrophotometric method).	—

Measure

Time frame

1. Pharmacokinetic measures: Plasma concentration of physostigmine and hyoscine tested at following intervals. Period 1: pre-dose and at intervals up to 96 hrs after the patch application. Period 2: pre-dose and at intervals up to 240 hours after application of the first patch. (test method for PK measures was liquid chromatography tandem mass spectrometry (LC-MS-MS) method). 2. Pharmacodynamic measures: Blood measurement of red cell acetylcholinesterase (AChE) activity tested at the following intervals. Period 1: pre-dose and at intervals up to 96 hrs after the patch application. Period 2: pre-dose and at intervals up to 240 hours after application of the first patch. (test method for PK measures was validated spectrophotometric method).

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026