PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and … (NCT02113163) | Clinical Trial Compass
CompletedPhase 1
PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
United States32 participantsStarted 2014-03
Plain-language summary
The primary objective of the study is to contrast the pharmacokinetic profiles of metformin and EPA delivered separately as co-administered products (metformin hydrochloride or Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to evaluate the safety and tolerability of single and repeat single doses of TP-101.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Signed informed consent executed prior to protocol screening assessments;
* Men or women 18 to 65 years of age, inclusive (Women may be surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are postmenopausal for \>1 year. Women who are of childbearing potential must agree to practice adequate contraception one month before the first dose of study medication and up to Day 16 of the study. Adequate contraception may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms or diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal methods.);
* No history of chronic diseases, except for subjects with well-controlled hypertension or well-controlled hyperlipidemia;
* BMI ≤30kg/m2;
* No significant medical history including diabetes or hypertension complicated by hyperlipidemia (metabolic syndrome);
* Negative urine drug and alcohol tests at Screening; and,
* No metformin or omega-3 products within 2 months.
Exclusion Criteria:
* Abnormal findings on physical examination, EKG, vital signs, and clinical laboratory testing, in the judgment of the investigator;
* Allergies to fish or shellfish;
* Impaired renal function (calculated eGFR \<60 mL/min);
* Abnormal laboratory values for T3, T4 and TSH at the Screening Visit;
* Aspartate aminotransferase/alanine aminotransferase (AST/ALT) \>2x upper limits of normal (ULN) or serum bilirubin \…
What they're measuring
1
AUC following single and repeat single oral administration of metformin eicosapentaenoate, metformin hydrochloride and Vascepa
Timeframe: PK samples at 0, 0.5, 1, 2, 4, 8, and 12 hours following drug administration