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NCT01888341 · ClinicalTrials.gov registry record · Phase 1

Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition

A Phase 1 study, sponsored by Dr. Reddy's Laboratories Limited.

Completed
Registry status
Phase 1
Development phase
41
Enrollment target

NCT01888341: Completed Phase 1 study, sponsored by Dr. Reddy's Laboratories Limited.

NCT01888341 is a Phase 1 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01888341, a Phase 1 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target

Study Summary

The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions

Interventions

  • DRUG Isotretinoin

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2002-08
Est. Completion 2002-08
Phase Phase 1
Dr. Reddy's Laboratories Limited

52 total trials

What the finished NCT01888341 record still lists

NCT01888341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 1 intervention - of which Isotretinoin is the first listed.

NCT01888341 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01888341 about?

NCT01888341 is a clinical study titled "Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition". The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions

What is the current status of trial NCT01888341?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2002-08. Estimated completion is 2002-08.

What interventions are being tested in trial NCT01888341?

The interventions under investigation include: Isotretinoin (DRUG).

Who is sponsoring clinical trial NCT01888341?

This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01888341's enrollment target sits among peer trials

41 1125th of 2000 higher than 871 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 NCT01888341, the US trial registry maintained by the National Library of Medicine. NCT01888341 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.