Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-14

Study Completion Date

2018-03-29

Brief Summary

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The purpose of this trial to compare the pharmacokinetic characteristics of YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2, Vd/f, CL/f.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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YNP-1807 Tablet(Pregabalin 330mg)

YNP-1807(Pregabalin 330mg), QD

Group Type EXPERIMENTAL

YNP-1807 330Mg Tablet

Intervention Type DRUG

330 mg oral administered (QD)

Lyrica Capsule(Pregabalin 150mg)

Lyrica Capsule(Pregabalin 150mg), BID

Group Type ACTIVE_COMPARATOR

Lyrica 150Mg Capsule

Intervention Type DRUG

150 mg oral administered (BID)

Interventions

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Lyrica 150Mg Capsule

150 mg oral administered (BID)

Intervention Type DRUG

YNP-1807 330Mg Tablet

330 mg oral administered (QD)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 19 years to 55 years healthy volunteers adult at screening visit
* For male, weight is more than 55 kg, for female, weight is more than 50 kg.
* Body mass index(BMI) value : 18.5 to 25.0 kg/m2
* If female, should be included one at least as following

* menopausal(menstruation for 2 years minimum)
* surgery infertility

Exclusion Criteria

* Any history of drug overdose or dependence
* Female who is pregnant or nursing
* AST, ALT \> ULN\*1.25
* Total bilirubin \> ULN\*1.5
* CPK \> ULN\*1.5

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes