Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR 25 mg/5 mg/1000 mg Extended- Release Tablets

Korábbi kezelés

• Used any hormone replacement therapy within 3 months prior to the first dose of study medication.
• Used any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
• Used CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
• History or evidence of drug dependence.
• Participant who had received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
• Participant who had donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever was greater.
• Used any prescribed medications within 14 days prior to the first dose of study medication.
• Used any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
• Used grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
• Ingested any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), recreational drugs within 48 hours prior to the first dose of study medication.

Más betegség

• History of allergic responses to Empagliflozin, Linagliptin, Metformin or other related drugs, or any of its formulation ingredients.
• Any disease or condition like diabetes, psychosis or others, which compromised the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, Central nervous system or any other body system.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• A positive hepatitis screen (included subtypes B \& C).
• A positive test result for HIV antibody.
• History of difficulty in swallowing or of any gastrointestinal disease, which affected drug absorption.
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the participant's participation in this study.
• History or presence of cardiovascular disorders.
• History of acute and chronic metabolic acidosis.
• History of genital mycotic infections.
• History of severe and disabling arthralgia.
• History of bullous pemphigoid.
• History of recurrent urinary tract infection

Laborértékek

• Had significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female participants)].
• Ingested any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
• Participant with Serum Lactate higher than upper limit of normal range.
• Participant with Serum Creatinine higher than upper limit of normal range.

Egyéb

• History or presence of bronchial asthma.
• Intolerance to venipuncture.
• Institutionalized participant.
• Presence of ketone during urine analysis.
• Participant with Estimated Glomerular Filtration Rate was less than 60 ml/min/1.73 m2 during screening.
• History or presence of hypoglycemia.
• History or sign and symptoms of pancreatitis.

• Age: 18 to 55 years old, both inclusive.
• Gender: Male and/or non-pregnant, non-lactating female. A. Female of child-bearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days of the first dose of study medication. They used an acceptable form of contraception.
  • For female of child-bearing potential, acceptable forms of contraception included the following:
• Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.
• Females were not considered of child-bearing potential if one of the following was reported and documented on the medical history:
• Postmenopausal with spontaneous amenorrhea for at least 12 consecutive months without other medical explanation, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months.
• 18.5 to 30.0 kg/m2, both inclusive; BMI values were rounded off to one significant digit after decimal point (e.g. 30.04 rounded down to 30.0, while 18.45 rounded up to 18.5).
• Able to communicate effectively with study personnel.
• Non-alcoholic, non-smoker and non-tobacco user (i.e. had no past history of drinking alcohol, smoking and tobacco consuming for at least one year prior to study).
• Normal or clinically non-significant ECG recording during screening.
• Willing to provide written informed consent to participate in the study.
• All participants were judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which included: a) A physical examination (clinical examination) with no clinically significant finding.