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

ConditionDiabetes Mellitus (Type 2)

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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Administration of UI087
Drug
1 tablet, once a day (Test)
Administration of UIC202506, UIC202507, UIC202508
Drug
1 tablet, once a day (Reference)

Treatment groups

44 Participants

are divided into 2 treatment groups

Group A: UI087Experimental treatment 1 intervention

Group B: UIC202506, UIC202507, UIC202508Active comparator 1 intervention