Trials / Completed
CompletedNCT01224717
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
A Phase I, Partially Blinded, Randomized, Placebo Controlled, Active Comparator Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Post-menopausal Women After Daily Oral Doses of PTH134
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Novartis · Industry
- Sex
- Female
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PTH134 | |
| DRUG | Placebo | |
| DRUG | Forsteo |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2011-04-01
- First posted
- 2010-10-20
- Last updated
- 2011-05-13
Locations
4 sites across 2 countries: Denmark, Germany
Source: ClinicalTrials.gov record NCT01224717. Inclusion in this directory is not an endorsement.