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Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women
NCT01721993 · View on ClinicalTrials.gov ↗
Study Summary
THAR2011-1 is a Phase I, single dose, open-label dose-escalation study to determine the safety, absolute bioavailability, dose proportionality, and pharmacokinetics of T121 in healthy postmenopausal women. The study is expected to identify a safe dose that can be further tested in subsequent multiple dose studies comparing the safety, PK and pharmacodynamics (PD) of T121 with the currently marketed IV zoledronic acid (Zometa).
Conditions Studied
Interventions
- DRUG Zoledronic acid
- DRUG T121
Study Locations (1)
Minnesota
- Prism Clinical Research — Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01721993
The ClinicalTrials.gov registry entry for NCT01721993 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thar Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy Postmenopausal Women appearing as the primary indexed condition, and to 2 interventions — of which Zoledronic acid is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01721993 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01721993 about?
NCT01721993 is a clinical study titled "Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women". THAR2011-1 is a Phase I, single dose, open-label dose-escalation study to determine the safety, absolute bioavailability, dose proportionality, and pharmacokinetics of T121 in healthy postmenopausal women. The study is expected to identify a safe dose that can be further tested in subsequent multipl...
What is the current status of trial NCT01721993?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2013-01. Estimated completion is 2014-08.
What conditions does trial NCT01721993 study?
This clinical trial studies the following conditions: Healthy Postmenopausal Women. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01721993?
The interventions under investigation include: Zoledronic acid (DRUG), T121 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01721993?
This trial is sponsored by Thar Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01721993 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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