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NCT02603770 · ClinicalTrials.gov registry record · Phase 1

Compare Pharmacokinetic(PK) Profiles of XZK vs Lovastatin in Healthy Male Volunteers

A Phase 1 study of Lipid Metabolism Disorder, sponsored by Luye Pharma Group.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT02603770: Completed Phase 1 study of Lipid Metabolism Disorder, sponsored by Luye Pharma Group.

NCT02603770 is a Phase 1 study of Lipid Metabolism Disorder that has completed, run by Luye Pharma Group. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02603770, a Phase 1 study of Lipid Metabolism Disorder, has completed, sponsored by Luye Pharma Group.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

The objective of this study is to compare laboratory tests profiles of a botanic drug XueZhiKang (XZK) 300 mg capsules versus a marketed drug Lovastatin 20 mg tablets in healthy male volunteers between 18 and 50 years of age.

Primary Outcome

PK Samples drawn at 0 (within 30 minutes prior to dosing), 0.5, 1,2,3,4 (+/- 5 min), 6,8,12 and 24 hour (+/- 15 min) after dosing on Day 1 and Day 11

Conditions Studied

Interventions

  • DRUG Lovastatin
  • DRUG XueZhiKang

Study Locations (1)

California

  • NRC Research Institute - Orange

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2015-11
Est. Completion 2016-02
Phase Phase 1
Luye Pharma Group

22 total trials

What the finished NCT02603770 record still lists

NCT02603770 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 1 condition, with Lipid Metabolism Disorder appearing as the primary indexed condition, and to 2 interventions - of which Lovastatin is the first listed.

NCT02603770 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT02603770 about?

NCT02603770 is a clinical study titled "Compare Pharmacokinetic(PK) Profiles of XZK vs Lovastatin in Healthy Male Volunteers". The objective of this study is to compare laboratory tests profiles of a botanic drug XueZhiKang (XZK) 300 mg capsules versus a marketed drug Lovastatin 20 mg tablets in healthy male volunteers between 18 and 50 years of age.

What is the current status of trial NCT02603770?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2015-11. Estimated completion is 2016-02.

What conditions does trial NCT02603770 study?

This clinical trial studies the following conditions: Lipid Metabolism Disorder.

What interventions are being tested in trial NCT02603770?

The interventions under investigation include: Lovastatin (DRUG), XueZhiKang (DRUG).

Who is sponsoring clinical trial NCT02603770?

This trial is sponsored by Luye Pharma Group, which has 22 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02603770 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Lipid Metabolism Disorder

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 NCT02603770's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 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 NCT02603770, the US trial registry maintained by the National Library of Medicine. NCT02603770 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.