{"id":"10c17e91-024a-5b74-9330-742412334a42","stable_key":"4910e17b-aaec-52cd-b9e5-caca85d817ee:red-yeast-rice-nifedipine-null","predicate":"does_not_change_tested","statement":"One 600 mg LipoCol Forte capsule did not significantly change the measured pharmacokinetics of 5 mg nifedipine in 14 volunteers.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"neutral","is_public":true,"mechanism_event_id":"e932b187-f504-5e59-a8cc-68b1bad9a35a","mechanism_event_label":"The predicted enzyme interaction was not demonstrated in this tested regimen.","subject":{"id":"30978ef1-162a-52bd-bb88-2e506565f5bc","slug":"lipocol-forte-2012","display_name":"LipoCol Forte red yeast rice preparation studied in 2012","entity_type_key":"drug"},"object":{"id":"497db216-c085-550d-a4f3-9d5f8b9db99a","slug":"human-nifedipine-exposure","display_name":"Human nifedipine plasma exposure","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"e932b187-f504-5e59-a8cc-68b1bad9a35a","stable_key":"4910e17b-aaec-52cd-b9e5-caca85d817ee:red-yeast-rice-nifedipine-null-event","event_type":"observed_relationship","label":"The predicted enzyme interaction was not demonstrated in this tested regimen.","description":"One 600 mg LipoCol Forte capsule did not significantly change the measured pharmacokinetics of 5 mg nifedipine in 14 volunteers.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"30978ef1-162a-52bd-bb88-2e506565f5bc","slug":"lipocol-forte-2012","display_name":"LipoCol Forte red yeast rice preparation studied in 2012","entity_type_key":"drug"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"497db216-c085-550d-a4f3-9d5f8b9db99a","slug":"human-nifedipine-exposure","display_name":"Human nifedipine plasma exposure","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"1c59d504-7042-5922-b484-0819e3b9a93d","slug":"nifedipine","display_name":"Nifedipine","entity_type_key":"small_molecule"},"role":"context_participant","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""},{"entity":{"id":"54e95ff1-4ffa-5e6f-a4cb-b47e5d2a5bda","slug":"cyp3a4","display_name":"Human cytochrome P450 3A4","entity_type_key":"protein"},"role":"context_participant","stoichiometry":null,"state_label":"","sequence_order":3,"notes":""}]},"contexts":[{"dimension":"evidence_access","value_text":"Primary full text PMC3513969","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Human fasted-state single-dose pharmacokinetic comparison.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"A null result for this dose does not exclude other drugs, preparations or exposures.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Red yeast rice collection; species, compartment, exposure, co-substrates and manipulation remain explicit.","comparator":null,"unit":null,"notes":"","entity":{"slug":"red-yeast-rice","display_name":"Red yeast rice","entity_type_key":"chemical_species"}},{"dimension":"plain_language","value_text":"The predicted enzyme interaction was not demonstrated in this tested regimen.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[23227093] Interaction between Red Yeast Rice and CYP450 Enzymes/P-Glycoprotein and Its Implication for the Clinical Pharmacokinetics of Lovastatin. · 2012 · https://pubmed.ncbi.nlm.nih.gov/23227093/ · DOI 10.1155/2012/127043","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"dd7a37c6-00b5-57fa-a869-ca9d2e68dddf","evidence_kind":"source_excerpt","locator":"Lines 156-162","start_line":156,"end_line":162,"excerpt":"## red-yeast-rice-nifedipine-null\nThe predicted enzyme interaction was not demonstrated in this tested regimen.\nOne 600 mg LipoCol Forte capsule did not significantly change the measured pharmacokinetics of 5 mg nifedipine in 14 volunteers.\nModel: Human fasted-state single-dose pharmacokinetic comparison.\nLimitations: A null result for this dose does not exclude other drugs, preparations or exposures.\nEvidence access: Primary full text PMC3513969\n[23227093] Interaction between Red Yeast Rice and CYP450 Enzymes/P-Glycoprotein and Its Implication for the Clinical Pharmacokinetics of Lovastatin. · 2012 · https://pubmed.ncbi.nlm.nih.gov/23227093/ · DOI 10.1155/2012/127043","model_system":"Human fasted-state single-dose pharmacokinetic comparison.","directness":"reported_statement","verification_status":"source_derived_draft","notes":"Original curation paraphrase; 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