A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults: Fed State Study

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-50
SponsorAJU Pharm Co., Ltd.

About this trial

To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults after taking the drugs with food (fed state).

Eligibility criteria

Qualifiers

Healthy adult volunteers aged 19 to 50 years at the time of screening.

Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.

Male subjects must weigh ≥50 kg.

Female subjects must weigh ≥45 kg.

Disqualifiers

Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.

Participation in any clinical trial involving investigational products within 6 months prior to the first dose.

Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.

History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).

Trial design

Treatments tested in this trial

  • Comparator 1
  • Comparator 2
  • Test Drug

Treatment groups

32 Participants
are divided into 2 treatment groups

Sponsors and collaborators