Clinical pharmacological study of TTS-NTG in healthy volunteers.

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A transdermal therapeutic system (TTS) containing nitroglycerin (NTG) was applied to 11 healthy male volunteers. The application doses used in this study were of two .different dosage strengths (TTS-NTG 25 mg/10 cm2 and TTS-NTG 50 mg/20 cm2). Plasma NTG concentration was measured by using gas chromatography-mass spectrometry (GC-MS), with 15N-NTG as internal standard. Plasma concentration rose clearly at 1-2 hours after application of the system, and the concentration maintained a steady level .all throughout the application. Mean plasma levels over the interval of time 2-24 hours after application of TTS NTG 50 mg/20 cm2 were approximately 2-fold that of TTS-NTG 25 mg/10 cm2. In the data of the subjective symptoms, headache and/or head heaviness were reported much more frequently than other symptoms, and these symptoms grew in intensity with increase of the dosage strength.
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