Drug Interactions Clinical Trial
Official title:
Microgynon Riociguat Drug Interaction Study to Investigate the Effect of Riociguat 2.5 mg 3 Times Daily Multiple-dose Treatment on the Plasma Concentrations of / Exposure to Levonorgestrel and Ethinyl Estradiol in Healthy Postmenopausal Women in a 2-fold Crossover Design
Physicians might be concerned that Adempas may have a metabolic interaction with oral contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information regarding lack of potential pharmacokinetic interaction has been communicated; there is a need for more re-assurance and further data that there is no interaction between Adempas and OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in the least vulnerable population for these purposes, i.e. healthy postmenopausal women, is considered adequate to inform about safe use of Adempas with OCs.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Completed |
NCT01925638 -
Effect of Ketoconazole on the Pharmacokinetics of Refametinib
|
Phase 1 | |
| Completed |
NCT00621699 -
Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00442585 -
S(+)-Ibuprofen Effects on Asprin Treated Volunteers
|
Phase 1 | |
| Completed |
NCT00200759 -
Drug Interactions and Bioavailability of Cranberry
|
Phase 1 | |
| Active, not recruiting |
NCT06401863 -
Shared Decision for Drug Interactions in Oral Anticoagulation
|
N/A | |
| Completed |
NCT00915746 -
A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT03748745 -
A Drug-drug Interaction Study of SH229 Tablets and Daclatasvir Dihydrochloride Tablets in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03324685 -
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
|
Phase 1 | |
| Completed |
NCT05433896 -
Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions
|
Phase 1 | |
| Recruiting |
NCT03307863 -
Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy
|
Phase 4 | |
| Completed |
NCT02706535 -
A Cross-over Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics (PK) of GSK525762 in Healthy Female Subjects of Non Child Bearing Potential
|
Phase 1 | |
| Completed |
NCT02147808 -
A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02097953 -
Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin
|
Phase 0 | |
| Completed |
NCT01364987 -
Pharmacokinetic Interaction Study to Assess the Effect of ASP015K on Mycophenolate Mofetil in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00709982 -
A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM) /Ethinyl Estradiol (EE) in Healthy Women.
|
Phase 1 | |
| Completed |
NCT00810303 -
Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2
|
Phase 1 | |
| Completed |
NCT04252300 -
Study to Learn the Effect of Drug BAY1817080 on the Way the Body Absorbs, Distributes and Excretes Another Drug Rosuvastatin in Healthy Adult Participants
|
Phase 1 | |
| Completed |
NCT02576366 -
Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus
|
Phase 4 | |
| Completed |
NCT01886209 -
Phase 1 PK Interaction Study Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects
|
Phase 1 |