| Title |
Lack of a Pharmacokinetic Interaction Between SYM-1219 Granules Containing 2 Grams of Secnidazole and a Combined Oral Contraceptive in a Phase 1, Randomized, Open-Label Study in Healthy Female Volunteers
|
|---|---|
| Published in |
Advances in Therapy, October 2016
|
| DOI | 10.1007/s12325-016-0411-9 |
| Pubmed ID | |
| Authors |
Helen S. Pentikis, Nikki Adetoro, Carol J. Braun |
| Abstract |
Bacterial vaginosis (BV) is a serious infection that is the most common vaginal infection in women of childbearing potential. SYM-1219 is a novel, granule formulation containing 2 g of secnidazole that is being developed as a single, oral dose to treat women with BV. Because many of the women diagnosed with BV use hormonal contraception, the effect of SYM-1219 on the pharmacokinetics (PK) of commonly prescribed oral contraceptive drugs, ethinyl estradiol (EE2), and norethindrone (NET) was evaluated. This two-period, randomized, open-label study examined effects in 54 healthy female subjects. During the first period of the study, each subject received EE2 0.035-mg/NET 1-mg tablets. During the second period of the study, subjects were randomized to receive either EE2 0.035-mg/NET 1-mg tablets with concomitant 2-g SYM-1219 or 2-g SYM-1219 followed by EE2 0.035-mg/NET 1-mg tablets 1 day later. The PK of EE2 and NET were analyzed for 24 h following administration. Coadministration of SYM-1219 and EE2/NET, either on the same day or 1 day apart, had no clinically relevant effects on the bioavailability of EE2 or NET. The combined use of SYM-1219 with EE2/NET was well tolerated. Taken together, these results indicate that contraceptive efficacy should be maintained during coadministration of SYM-1219 and EE2/NET. SYM-1219 is a valuable single-dose treatment option for women with BV that will not interfere with combined oral contraceptive methods. Symbiomix Therapeutics. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Science communicators (journalists, bloggers, editors) | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 27 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 27 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Other | 4 | 15% |
| Researcher | 4 | 15% |
| Student > Master | 3 | 11% |
| Student > Ph. D. Student | 2 | 7% |
| Student > Doctoral Student | 2 | 7% |
| Other | 3 | 11% |
| Unknown | 9 | 33% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 5 | 19% |
| Biochemistry, Genetics and Molecular Biology | 5 | 19% |
| Medicine and Dentistry | 4 | 15% |
| Environmental Science | 1 | 4% |
| Psychology | 1 | 4% |
| Other | 1 | 4% |
| Unknown | 10 | 37% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 17 October 2016.
All research outputs
#18,475,157
of 22,893,031 outputs
Outputs from Advances in Therapy
#1,637
of 2,355 outputs
Outputs of similar age
#241,656
of 319,595 outputs
Outputs of similar age from Advances in Therapy
#26
of 37 outputs
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