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[Pharmacological study on treptilamine in man/study on tolerability (author's transl)]
Arzneimittel-Forschung
|January 1, 1979
Summary
Treptilamine hydrochloride, a spasmolytic agent, was evaluated for safety and efficacy in human volunteers. Intravenous administration caused transient blood pressure drops and accommodation range restriction, while oral doses also affected accommodation.
Area of Science:
- Pharmacology
- Clinical Trials
Background:
- Treptilamine hydrochloride (treptilamine) demonstrated spasmolytic effects in animal studies.
- Human compatibility and efficacy require investigation before clinical use.
Purpose of the Study:
- To assess the safety and tolerability of treptilamine hydrochloride in human volunteers.
- To verify the spasmolytic effects of treptilamine hydrochloride in a double-blind, placebo-controlled study.
Main Methods:
- Pilot study: 6 volunteers received oral (30-50 mg) and intravenous (10-20 mg) treptilamine.
- Double-blind study: 20 volunteers received 40 mg oral or 15 mg intravenous treptilamine against placebo.
- Evaluated compatibility, circulation, accommodation range, and clinicochemical parameters.
Main Results:
- Intravenous treptilamine significantly decreased systolic blood pressure (15 mmHg for 10 min at 15 mg dose) and restricted accommodation range (40%).
- Oral treptilamine (40 mg) also restricted accommodation range (30%) and caused tiredness; no circulation changes observed.
- Side effects included transient drowsiness and burning sensation at the injection site.
Conclusions:
- Treptilamine hydrochloride exhibits dose-dependent effects on blood pressure and accommodation in humans.
- While showing some efficacy, potential side effects warrant careful consideration for clinical application.