Status:
COMPLETED
Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers
Lead Sponsor:
Yungjin Pharm. Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
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 AU...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03261427
Start Date
September 14 2017
End Date
March 29 2018
Last Update
July 10 2019
Active Locations (1)
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1
Severance Hospital
Seoul, Yonsei-ro Seodaemun-gu, South Korea, 120-752