{"id":"7d232982-9153-5f3b-a076-6a9cdfd0c6e4","stable_key":"7484635e-cc8f-5cd6-a978-6dc5775a7db5:berberine-clinical-statin-null","predicate":"no_obvious_pharmacokinetic_change_in","statement":"No clinically obvious pharmacokinetic interaction with simvastatin was detected in the tested berberine-chloride combination regimen.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"40735b44-e23a-5863-80fd-96f65113ca2a","mechanism_event_label":"The measured result limits a blanket claim that every relevant drug concentration must rise.","subject":{"id":"7bbe0633-b2f1-510f-adc0-3c4d0ddad05d","slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"},"object":{"id":"3c530768-ff75-596f-9135-4def848bd08a","slug":"simvastatin-plasma-exposure","display_name":"Plasma simvastatin exposure","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"40735b44-e23a-5863-80fd-96f65113ca2a","stable_key":"7484635e-cc8f-5cd6-a978-6dc5775a7db5:berberine-clinical-statin-null-event","event_type":"observed_intervention","label":"The measured result limits a blanket claim that every relevant drug concentration must rise.","description":"No clinically obvious pharmacokinetic interaction with simvastatin was detected in the tested berberine-chloride combination regimen.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"b7de977d-fed9-5b1c-8138-fd951442b067","slug":"simvastatin","display_name":"Simvastatin","entity_type_key":"small_molecule"},"role":"measured_drug","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"7bbe0633-b2f1-510f-adc0-3c4d0ddad05d","slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"3c530768-ff75-596f-9135-4def848bd08a","slug":"simvastatin-plasma-exposure","display_name":"Plasma simvastatin exposure","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/berberine-research/30587933.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"f82b466cc2942fd70940935e1fa42174f135036017a589bc7fa86388e6f9e4be\", \"start_char\": 0, \"end_char\": 2118, \"text_sha256\": \"f82b466cc2942fd70940935e1fa42174f135036017a589bc7fa86388e6f9e4be\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Open-label randomized parallel pharmacokinetic study","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Single-dose and seven-day repeated treatment; berberine chloride alone or combined","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Short, small healthy-volunteer study. Absence of an obvious interaction here does not establish unrestricted long-term safety in patients.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Berberine research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"}},{"dimension":"organism","value_text":"Sixty healthy Chinese participants across five groups","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"The measured result limits a blanket claim that every relevant drug concentration must rise.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[berberine-p30587933] Pharmacokinetic interactions and tolerability of berberine chloride with simvastatin and fenofibrate: an open-label, randomized, parallel study in healthy Chinese subjects. (2019). https://pubmed.ncbi.nlm.nih.gov/30587933/ DOI: 10.2147/dddt.s185487","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Simvastatin and fenofibrate exposure","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"9c9afddb-b8d2-5c0b-8ed1-8496524cd98e","evidence_kind":"source_excerpt","locator":"Lines 935-946","start_line":935,"end_line":946,"excerpt":"### berberine-clinical-statin-null\nNo clinically obvious pharmacokinetic interaction with simvastatin was detected in the tested berberine-chloride combination regimen.\nCondition category: normal\nnutrient_topic: Berberine research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: The measured result limits a blanket claim that every relevant drug concentration must rise.\norganism: Sixty healthy Chinese participants across five groups\ntissue_or_cell_type: Simvastatin and fenofibrate exposure\nexperimental_model: Open-label randomized parallel pharmacokinetic study\nlimitations: Short, small healthy-volunteer study. Absence of an obvious interaction here does not establish unrestricted long-term safety in patients.\nexposure: Single-dose and seven-day repeated treatment; berberine chloride alone or combined\nevidence_span: {\"source_cache\": \"artifacts/berberine-research/30587933.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"f82b466cc2942fd70940935e1fa42174f135036017a589bc7fa86388e6f9e4be\", \"start_char\": 0, \"end_char\": 2118, \"text_sha256\": \"f82b466cc2942fd70940935e1fa42174f135036017a589bc7fa86388e6f9e4be\"}\n[berberine-p30587933] Pharmacokinetic interactions and tolerability of berberine chloride with simvastatin and fenofibrate: an open-label, randomized, parallel study in healthy Chinese subjects. (2019). https://pubmed.ncbi.nlm.nih.gov/30587933/ DOI: 10.2147/dddt.s185487","model_system":"Open-label randomized parallel pharmacokinetic study","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [berberine-p30587933] Pharmacokinetic interactions and tolerability of berberine chloride with simvastatin and fenofibrate: an open-label, randomized, parallel study in healthy Chinese subjects. (2019). https://pubmed.ncbi.nlm.nih.gov/30587933/ DOI: 10.2147/dddt.s185487","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"9bb61e1d-e5cf-5b05-a9ca-409291f7a313","stable_key":"import-7484635e-cc8f-5cd6-a978-6dc5775a7db5","title":"Berberine: metabolism, nutrient connections and drug interactions (2026-09-17)","document_type":"imported_text","citation_label":"AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. 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