A Pharmacokinetic Study to Compare Co-administration of Repaglinide and Metformin HCl to Administration of Combination Preparation of Those Two Components

Overview[ - collapse ][ - ]

Purpose This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study. The objective of the study is to compare the pharmacokinetic properties after co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50 healthy male volunteers.
ConditionDiabetes Mellitus, Type 2
InterventionDrug: Repaglinide/Metformin combination, Repaglinide, Metformin
Drug: Repaglinide/Metformin combination, Repaglinide, Metformin
PhasePhase 1
SponsorDalim BioTech Co., Ltd.
Responsible PartyDalim BioTech Co., Ltd.
ClinicalTrials.gov IdentifierNCT01780051
First ReceivedJanuary 29, 2013
Last UpdatedMay 14, 2013
Last verifiedMay 2013

Tracking Information[ + expand ][ + ]

First Received DateJanuary 29, 2013
Last Updated DateMay 14, 2013
Start DateMarch 2013
Estimated Primary Completion DateApril 2013
Current Primary Outcome MeasuresAUCt and Cmax of repaglinide and metformin [Time Frame: Before study drug administration(0h) and after 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h of study drug administration.] [Designated as safety issue: No]
Current Secondary Outcome MeasuresAUC∞, Tmax, t1/2, CL/F and Vd/F of repaglinide and metformin [Time Frame: Before study drug administration(0h) and after 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h of study drug administration.] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Pharmacokinetic Study to Compare Co-administration of Repaglinide and Metformin HCl to Administration of Combination Preparation of Those Two Components
Official TitleAn Open-label, Randomized, Single-dose, 2-way Crossover Trial to Compare the Pharmacokinetics of Repaglinide2mg and MetforminHCl 500mg Complex to Combination Preparation of Repaglinide 2mg and MetforminHCl 500mg in Healthy Male Volunteers.
Brief Summary
This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover
study. The objective of the study is to compare the pharmacokinetic properties after
co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration
of combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50
healthy male volunteers.
Detailed Description
This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover
study. The objective of the study is to compare the pharmacokinetic properties after
co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration
of combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50
healthy male volunteers.

- All the subjects should be admitted one day prior to scheduled study date until 4pm to
Chonbuk National University Hospital Clinical Trial Center and they will be served with
the same dinner. After dinner, they should keep fast, they are just allowed to drink
water until 8am of the study date.

- According to the randomly designated order, all subjects will be administrated
with the study or reference products with 240mL of water at 9am(±2hours) on the
first date of the study. The study or the reference products should be swallowed
completely, and not to be chewed before swallowing.

- Study product : Repanorm M 2/500mg (Dalim BioTech Co., Ltd.)

- Reference products : Metformin HCl 500mg tablet, Repaglinide 2mg tablet

- Subjects have to fast for 4 hours post administration of the study or
reference drugs(water intake is not allowed for 1 hour before and after
the administration), and should follow standardized lunch after four
hours and dinner 9 hours later from the time of administration

- Assessment and laboratory test will be performed in accordance with
schedule written on the protocol

- After having 7 days of withdrawal period, the 2nd study period
will be done at 9am(±2hours). In contrast of the 1st period,
Sequence B which received the study product in 1st period will
take the reference drugs for the 2nd period, while the group
Sequence A which received reference drugs will take the study
drug. The steps of administration of drugs and process of
tests are the same with the 1st period
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: Repaglinide/Metformin combination, Repaglinide, Metformin
Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 1.
Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 2.
Drug: Repaglinide/Metformin combination, Repaglinide, Metformin
Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 1.
Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 2.
Study Arm (s)
  • Experimental: Sequence A
  • Experimental: Sequence B

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment48
Estimated Completion DateApril 2013
Estimated Primary Completion DateApril 2013
Eligibility Criteria
Inclusion Criteria:

1. Healthy male volunteers ages between 20 and 55 years at screening

2. Subject with Body Mass Index(BMI) with the range of 17.5 to 30.5kg/m2 and body weight
over 45kg

3. Signed informed consent with the date of signature

4. With ability to comply with all the scheduled visits, treatment plans; laboratory
tests and other processes.

Exclusion Criteria:

1. Positive of blood, kidney, endocrine, lung, gastro-intestinal, cardiovascular,
hepatic, psychiatric, nervous, allergy; or with past and present disease history or
symptoms that are clinically significant.

2. Any conditions that are likely to affect drug absorption. ex) gastrectomy

3. Positive on urine drug tests

4. History of drinking alcohol more than 12 ounces(360mL) of beer, 1.5 ounces(45mL) of
liquor; or 21 drinks/week(1drink = 5 ounces(150mL) of wine ) 6months prior to
screening

5. Participation in any other clinical studies within 2months prior to scheduled study
drug administration

6. With Blood pressure of ≥ 160 mmHg(Systolic blood pressure) or ≥ 90 mmHg(Diastolic
blood pressure) in sitting position at screening time.

7. History of any serious substance or alcohol abuse within one year prior to screening

8. Use of any drugs known to significantly induce or inhibit drug metabolizing enzyme
within 30days prior to scheduled study drug administration

9. Cigarette smoking of over 20 sticks per day.

10. Use of any prescription drugs or any over the counter drugs within 10days or
quintuple half life(whichever is longer) prior to scheduled study drug administration

11. Donation of whole blood within 2months or any blood products within 1month, prior to
scheduled study drug administration

12. Disability to comply with the guidelines written on the protocol

13. Severe acute/chronic medical, physical disorder or laboratory test abnormality that
are likely to alter the study result and increase the risk by participating in the
study and study drug administration

14. Hypersensitivity to chief component or excipient of Repaglinide

15. History of hypersensitivity to Metformin or Biguanide class of drugs

16. With renal failure or renal inadequacy caused by cardiovascular shock, acute
myocardial infarction and sepsis

17. With Congestive heart failure and undergoing drug treatment.

18. Patients undergoing radioactive iodine uptake tests, such as intravenous urography,
intravenous cholangiography, angiography, computed tomography using radioactive
iodine

19. Patients with type 1 diabetes, acute or chronic metabolic acidosis including diabetic
ketoacidosis associated with or without coma

20. With serious infection or trauma

21. Malnutrition, starvation; weakness; pituitary insufficiency or adrenal insufficiency

22. Patients with hepatic failure, pulmonary infarction, serious pulmonary dysfunction,
or other conditions associated with hypoxemia, alcohol abuser, or dehydration,
diarrhea; vomiting and gastro-intestinal disease

23. Proven to be unsuitable to participate in this clinical study by an investigator
GenderMale
Ages20 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01780051
Other Study ID NumbersRM0818-01
Has Data Monitoring CommitteeNo
Information Provided ByDalim BioTech Co., Ltd.
Study SponsorDalim BioTech Co., Ltd.
CollaboratorsNot Provided
Investigators Principal Investigator: Min-Gul Kim, doctor Chounbuk National University Hospital
Verification DateMay 2013

Locations[ + expand ][ + ]

Chounbuk National University Hospital
Jeonju, Jeonbuk, Korea, Republic of