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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: Completed Phase 1 study of Healthy Postmenopausal Women, sponsored by Thar Pharmaceuticals.
NCT01721993 is a Phase 1 study of Healthy Postmenopausal Women that has completed, run by Thar Pharmaceuticals. The registered enrollment target is 71 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Pharmacokinetic parameters will include maximum serum concentration (Cmax), time corresponding to the occurrence of maximum serum concentration (tmax), area under the serum concentration-time curve from zero to the last observed quantifiable concentration (AUCtlast), area under the serum concentration-time curve from time zero to infinity (AUC), terminal exponential half-life (t1/2,z), absolute bioavailability, cumulative amount recovered in urine (Ae) and renal clearance (CLr).
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 |
What the finished NCT01721993 record still lists
NCT01721993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01721993's enrollment target sits among peer trials
71 747th of 2000 higher than 1,252 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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