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IS-5-MN T1 is an extended-release (ER) tablet formulation of isosorbide-5-mononitrate (40 mg) developed by Qilu Pharmaceutical. Isosorbide-5-mononitrate is an organic nitrate vasodilator that acts as a nitric oxide donor. Upon administration, it undergoes biotransformation to release nitric oxide, which activates soluble guanylyl cyclase (sGC) in vascular smooth muscle cells. This activation increases intracellular cyclic GMP (cGMP) levels, leading to smooth muscle relaxation and vasodilation, which reduces cardiac preload and afterload. IS-5-MN T1 was evaluated in a completed Phase 1 bioequivalence study (NCT03557580) in healthy Chinese subjects under fed conditions, comparing it to the reference listed drug ISMO Retard 40 mg for the prevention and management of angina pectoris.
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