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Nebivolol Tablets 5 mg Relative to Nebilet Tablets 5 mg - Trial NCT06248099

Access comprehensive clinical trial information for NCT06248099 through Pure Global AI's free database. This Phase 1 trial is sponsored by Bio-innova Co., Ltd and is currently Not yet recruiting. The study focuses on Healthy Subjects. Target enrollment is 46 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06248099
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06248099
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Nebivolol Tablets 5 mg Relative to Nebilet Tablets 5 mg
A Bioequivalence Study of Nebivolol Tablets 5 mg Relative to Nebilet Tablets 5 mg in Healthy Thai Volunteers Under Fasting Condition

Study Focus

Healthy Subjects

Nebivolol-Test product

Interventional

drug

Sponsor & Location

Bio-innova Co., Ltd

Timeline & Enrollment

Phase 1

Jul 09, 2024

Sep 14, 2024

46 participants

Primary Outcome

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t),Maximal measured plasma concentration (Cmax)

Summary

The study is to compare the rate and extent of absorption of a generic formulation with that
 of a reference for mulation when given as equal labeled dose. The study will be randomized,
 open-label, single dose, two way crossover design with two-period, two-treatment and
 two-sequence under fasting condition and at least 28 days washout period between the doses.

ICD-10 Classifications

Occupational health examination
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmful
Routine child health examination
Examination and observation for other reasons

Data Source

ClinicalTrials.gov

NCT06248099

Non-Device Trial