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Clinical Trials/NCT02940314
NCT02940314
Completed
Phase 1

A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers

Hanmi Pharmaceutical Company Limited0 sites36 target enrollmentMarch 2016
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ConditionsOveractive Bladder
InterventionsHIP1503HGP1103
DrugsHIP1503HGP1103

Overview

Phase
Phase 1
Intervention
HIP1503
Conditions
Overactive Bladder
Sponsor
Hanmi Pharmaceutical Company Limited
Enrollment
36
Primary Endpoint
AUClast
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to compare the safety and pharmacokinetic characteristics after administration of HIP1503 and HGP1103 in healthy male volunteers.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
Hanmi Pharmaceutical Company Limited
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Healthy male volunteers, age 19 to 45 years.
  • •The result of Body Mass Index(BMI) 17.5 kg/m2\~ 30.5 kg/m2, body weight over 55kg.
  • •Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing.

Exclusion Criteria

  • •Presence of medical history or a concurrent disease, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
  • •Medical history of Gastrointestinal Diseases that effects drug absorption (esophageal disease, chronic disease) or surgery( except appendectomy , herniolaparotomy)
  • •sit SBP \> 140 mmHg, sit DBP \> 90 mmHg
  • •Alcohol or Drug abuse within 1 year

Arms & Interventions

sequence 1

HGP1103→HIP1503

Intervention: HIP1503

sequence 1

HGP1103→HIP1503

Intervention: HGP1103

Sequence 2

HIP1503→HGP1103

Intervention: HIP1503

Sequence 2

HIP1503→HGP1103

Intervention: HGP1103

Outcomes

Primary Outcomes

AUClast

Time Frame: 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)

Solifenacin Cmax

Time Frame: 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)

Secondary Outcomes

  • Solifenacin Tmax(0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14))
  • Solifenacin t1/2(0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14))
  • Solifenacin AUCinf(0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14))

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