A Study to Evaluate the Safety and Pharmacokinetics of UI087 Compared to Coadministration of UIC202506, UIC202507 and UIC202508 in Healthy Adult Volunteers Under Fasting Conditions

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorKorea United Pharm. Inc.

About this trial

This study was an open-label, randomized, single-dose, 2-sequence, 2-period, crossover study to evaluate the safety and pharmacokinetics of UI087 compared to coadministration of UIC202506, UIC202507 and UIC202508 in healthy adult volunteers under fasting conditions

Eligibility criteria

Qualifiers

Subjects aged 19 years or older at the screening visit

Subjects with a body weight ≥ 50 kg (≥ 45 kg for females) and a body mass index (BMI) between 18.0 and 30.0 kg/m² at the screening visit

BMI (kg/m²) = body weight (kg) / {height (m)}²

Subjects without clinically significant congenital or chronic diseases and without pathological symptoms or findings based on medical examination at the screening visit

Disqualifiers

Subjects with clinically significant diseases or a history of diseases involving the gastrointestinal, cardiovascular, endocrine, respiratory, hematologic/oncologic, infectious, renal and genitourinary, psychiatric/neurological, musculoskeletal, immune, ENT, dermatologic, or ophthalmologic systems

Subjects with a history of gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect drug absorption, or with gastrointestinal diseases

Subjects who have taken enzyme-inducing or inhibiting drugs (e.g., barbiturates) within 1 month prior to the first dose, or medications that may affect the clinical trial within 10 days prior to the first dose (Participation may be allowed depending on pharmacokinetic/pharmacodynamic properties such as interactions and half- life)

Subjects who have participated in another clinical trial or bioequivalence study and received an investigational product within 6 months prior to the first dose

Trial design

Treatments tested in this trial

  • Administration of UI087
  • Administration of UIC202506, UIC202507, UIC202508

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators