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NCT01875939 · ClinicalTrials.gov registry record · Phase 1

Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers

A Phase 1 study, sponsored by Wockhardt.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT01875939: Completed Phase 1 study, sponsored by Wockhardt.

NCT01875939 is a Phase 1 study that has completed, run by Wockhardt. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01875939, a Phase 1 study, has completed, sponsored by Wockhardt.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose). This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK 2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771, IV to WCK 2349, oral) in future clinical trials in patients.

Primary Outcome

To compare the pharmacokinetics of WCK 2349 following oral administration of 1000 mg of WCK 2349 (QD, one day) in healthy, adult, human subjects in fed and fasting state To determine the absolute bioavailability of WCK 2349 following oral administration of 1000 mg of WCK 2349 (QD, one day) with respect to intravenous administration of 800 mg of WCK 771 (QD, one day) in healthy adult human subjects in fasting state.Absolute bioavailability (F) of oral WCK 2349 as compared to intravenous WCK 771 f

Interventions

  • DRUG Oral WCK2349
  • DRUG IV WCK771

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2013-06
Est. Completion 2013-06
Phase Phase 1
Wockhardt

27 total trials

What the finished NCT01875939 record still lists

NCT01875939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 2 interventions - of which Oral WCK2349 is the first listed.

NCT01875939 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01875939 about?

NCT01875939 is a clinical study titled "Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers". This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose). This study would ascertain/confirm the therapeutically equivalent oral and IV dos...

What is the current status of trial NCT01875939?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2013-06. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01875939?

The interventions under investigation include: Oral WCK2349 (DRUG), IV WCK771 (DRUG).

Who is sponsoring clinical trial NCT01875939?

This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01875939's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01875939, the US trial registry maintained by the National Library of Medicine. NCT01875939 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.