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NCT01721993 · ClinicalTrials.gov registry record · Phase 1
Open Label Dose Escalation Phase I Study to Investigate the Safety and Pharmacokinetics of T121E01F and T121E02F in Healthy Postmenopausal Women
A Phase 1 study of Healthy Postmenopausal Women, sponsored by Thar Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT01721993 is a Phase 1 study of Healthy Postmenopausal Women that has completed, run by Thar Pharmaceuticals. The registered enrollment target is 71 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01721993, a Phase 1 study of Healthy Postmenopausal Women, has completed, sponsored by Thar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
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, categorized as Phase 1. 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.
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.
NCT01721993 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
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.
What interventions are being tested in trial NCT01721993?
The interventions under investigation include: Zoledronic acid (DRUG), T121 (DRUG).
Who is sponsoring clinical trial NCT01721993?
This trial is sponsored by Thar Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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