drugset / Trial / NCT02641990
Study of the Effect of ITCA 650 on the PK/PD of Oral Contraceptive in Healthy Female Subjects
RandomizedCrossoverQuadruple-blind
Summary
A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the effect of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora® (ethinyl estradiol 0.3 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy premenopausal female subjects.
Timeline
- Start
- 2015-12
- Primary completion
- 2016-02
- Completion
- 2016-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exenatide | Peptide | 20 ug | — |
| Subject | Exenatide | Peptide | 60 ug | — |
| Subject | Levonorgestrel | Small molecule | 0.15 mg | — |
| Subject | ethinyl estradiol | Small molecule | 0.3 mg | — |
Indications
No indication recorded.