CompletedPhase 1

Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.

Mexico48 participantsStarted 2023-01-16

Plain-language summary

The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose administration under fed conditions.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy adult male and female subjects aged ≥ 18 and ≤ 55 years.
✓. Subjects is a non-or ex-smoker (An ex-smoker is defined as someone who completely stopped smoking for at least 6 months before screening).
✓. With a weight ≥ 50.00 kg.
✓. With a body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 27.0 kg/m2. This BMI range covers both COFEPRIS (18.0 to 27.0 kg/m2) and GCC (18.5 to 30.0 kg/m2) requirements.
✓. Found healthy according to the clinical laboratory results and physical examination (performed within 28 days prior to the dosing on period 1).
✓. Have a normal 12-lead ECG and vital signs.
✓. Have laboratory test results within the laboratory's stated normal range; if not within this range, they must lack of clinical significance as judged by the PI or responsible physician.
✓. If the subject of the study is female and childbearing potential / fertile (a woman is considered fertile from first menstruation and until she becomes postmenopausal, or permanently sterile), and agrees to use ANY ONE of the following forms of effective contraception / birth control (but not limited to) from the time of enrollment into the study and until at least 7 days after the last study drug administration, as judged by the PI considering the pharmacology of IP(s):

Exclusion criteria

✕. Have any history of allergy or hypersensitivity to sitagliptin and metformin or to any of its metabolites/derivatives or related drugs or excipients.

What they're measuring

Peak Plasma Concentration (Cmax)

Timeframe: 48 hours

Area under the plasma concentration versus time curve (AUC) 0-t

Timeframe: 48 hours

Area under the plasma concentration versus time curve (AUC) 0-inf (Metformin only)

Timeframe: 48 hours

Trial details

NCT IDNCT06124547

SponsorGalenicum Health

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-13

View on ClinicalTrials.gov More Bioequivalence trials

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy adult male and female subjects aged ≥ 18 and ≤ 55 years.
✓. Subjects is a non-or ex-smoker (An ex-smoker is defined as someone who completely stopped smoking for at least 6 months before screening).
✓. With a weight ≥ 50.00 kg.
✓. With a body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 27.0 kg/m2. This BMI range covers both COFEPRIS (18.0 to 27.0 kg/m2) and GCC (18.5 to 30.0 kg/m2) requirements.
✓. Found healthy according to the clinical laboratory results and physical examination (performed within 28 days prior to the dosing on period 1).
✓. Have a normal 12-lead ECG and vital signs.
✓. Have laboratory test results within the laboratory's stated normal range; if not within this range, they must lack of clinical significance as judged by the PI or responsible physician.
✓. If the subject of the study is female and childbearing potential / fertile (a woman is considered fertile from first menstruation and until she becomes postmenopausal, or permanently sterile), and agrees to use ANY ONE of the following forms of effective contraception / birth control (but not limited to) from the time of enrollment into the study and until at least 7 days after the last study drug administration, as judged by the PI considering the pharmacology of IP(s):

Exclusion criteria

✕. Have any history of allergy or hypersensitivity to sitagliptin and metformin or to any of its metabolites/derivatives or related drugs or excipients.