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Completed

NCT Number: NCT03234244

HDDO-1614 Intervention Trial

Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study

Completed

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inha University Hospital

Junggu, Incheon, 22332, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body weight 50kg ≤ / BMI=18~29kg/㎡
  • A person who is determined to be eligible for the test through a physical examination or an interview
  • Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, urine test, serology test

Exclusion criteria

  • Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular
  • Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials
  • Any person who shows any of the following results in the screening test
  • AST or ALT > 2 times upper limit of normal range
  • Total Bilirubin > 2.0mg/dL
  • Glomerular filtration rate (eGFR) < 60mL / min/ 1.7㎡
  • Those who show signs of hypotension (systolic blood pressure ≤ 100mmHg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
  • Those who have a history of drug abuse or who have a positive urine drug test

Treatment and study plan

Bazedoxifene 20 mg

Drug

To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.

Cholecalciferol

Drug

To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.

Bazedoxifene 20mg and Cholecalciferol

Drug

For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.

Primary outcomes

  1. Drug-Drug Interaction

    Time frame: Day 1~Day 56

    To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol.

Secondary outcomes

  1. Pharmacokinetic Assessment

    Time frame: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours

    Bazedoxifene Maximum Plasma Concentration

  2. Pharmacokinetic Assessment

    Time frame: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours

    Bazedoxifene Area Under Curve

  3. Pharmacokinetic Assessment

    Time frame: Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour

    Maximun Plasma Concentration after correction of basal concentration of Cholecalciferol

  4. Pharmacokinetic Assessment

    Time frame: Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour

    Area Under Curve after correction of basal concentration of Cholecalciferol

Sponsors and collaborators

Lead sponsor

Hyundai Pharmaceutical Co., LTD.

Industry

Registry information

Official study title

A Randomized, Open-label, Single-dose Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of HDDO-16141 and HDDO-16142 in Healthy Adult Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 31, 2017
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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