NCT01928316 is a Phase 1 clinical trial of Mizolastine domestic (made in China) in Healthy, sponsored by Xian-Janssen Pharmaceutical Ltd..

Who is sponsoring NCT01928316?

NCT01928316 is sponsored by Xian-Janssen Pharmaceutical Ltd..

What drugs are being tested in NCT01928316?

Interventions in NCT01928316: Mizolastine domestic (made in China), Mizolastine (imported).

Is NCT01928316 still recruiting?

NCT01928316 is currently completed. Last updated 22 August 2013.

Last reviewed 2013-08-22 · How we verify

NCT01928316

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Bioequivalence Study of Home-made and Imported Mizolastine Tablets in Healthy Volunteers

Completed Phase 1 Last updated 22 August 2013

What this trial tests

Phase 1 trial testing Mizolastine domestic (made in China) in Healthy in 24 participants. Completed in 1 June 2009.

Timeline

1 June 2009

Primary endpoint
1 June 2009

1 June 2009

Quick facts

Lead sponsor	Xian-Janssen Pharmaceutical Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 June 2009
Primary completion	1 June 2009
Estimated completion	1 June 2009

Drugs / interventions tested

Mizolastine domestic (made in China) — full drug profile →
Mizolastine (imported) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Xian-Janssen Pharmaceutical Ltd. — full company profile →

Who can join

Adults 18 to 40, male only, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Mizolastine (imported): Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Mizolastine (domestic [made in China]): Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Mizolastine (imported): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Mizolastine (domestic [made in China]): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Mizolastine (imported): Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Mizolastine (domestic [made in China]): Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Days 1, 2, 8, and 9 (Pre dose and Post dose 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 28, 36, 48 and 60 hours)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

Sponsor's own description

The purpose of the study is to evaluate the bioequivalence (the way in which different forms of the same drug are absorbed in the body) of single-dose administration of domestic (made in China) mizolastine tablets and imported mizolastine tablets given at the same dose in healthy volunteers

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Xian-Janssen Pharmaceutical Ltd. trials

Trials by the same sponsor.

NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
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NCT06082986 — A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China · completed
NCT03617016 — Preliminarily Evaluate the Efficacy of Domperidone in Adult Chinese Participants With Functional Dyspepsia · Phase 4 · completed
NCT03220867 — Bioequivalence Study of Xian Risperdal Tablets Compared With Gurabo Risperdal Tablets Under Fasting and Fed Conditions i · Phase 1 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01928316 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Xian-Janssen Pharmaceutical Ltd.
Last refreshed: 22 August 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01928316.

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