Pharmacokinetic study of two orally formulated modified release tablets of Ferrous Sulfate 325mg and Sodium Ascorbate 562.4 mg in healthy volunteers under fasting and fed conditions.

INTERVENTION: Test Product: Ferro‐C, Dried ferrous sulfate 325mg and sodium ascorbate 562.4mg per modified release tablet Administered as single dose of one modified release tablet given orally with 240 mL of water under the supervision of the study site staff. There will be a washout period of at least 7 days from completion of dosing in one period to the start of dosing in the next period. During the fasting condition study, subjects will be randomly allocated to either test product treatment or the reference product treatment, following a wash out period, subjects will enter into another treatment phase to complete the cross over. During the fed condition study, the same procedure will apply. Under Fasting Condition: Participants will be fasted for at least 10 hours overnight before dosing and for 4 hours after dosing. Water will be restricted for 1 hour pre‐dose and 1 hour post‐dose. Participants will be provided with standard meals during their clinic stay from approximately 4 and 12 hours post dose. Also a snack will provided approximately at 8 hours after the study drug administration. Under Fed Condition: Subjects will be fasted at least 10 hours overnight and receive a standard breakfast served 30 minutes prior to study drug administration. This breakfast will supply around 927 kcal, about 50% of which are fat calories. Subjects will eat this meal in 30 minutes and study drug will be administered 30 mins after the start of meal. No additional food will be allowed for at least 5 hours post‐dose. CONDITION: Anaemia; ; Anaemia Blood ‐ Anaemia PRIMARY OUTCOME: To evaluate and determine the pharmacokinetics parameters (Cmax, AUC0‐t, AUC0‐inf and Tmax) of serum total iron between test and reference products under fasting conditions.[Blood samples will be collected before dosing (at ‐12.00, ‐6.00 and ‐1.00 hours) and at the following times after the dose: (1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 16.00, 20.00 and 24.00 hours).] SECONDARY OUTCOME: To compare the safety and tolerability of the treatments ; Safety will be evaluated during each study period, and for 7 days following study drug administration. ; An acute safety evaluation will be performed during each study period by recording spontaneously reported adverse events and by clinical assessments, including measurements of vital signs (blood pressure, heart rate, respiratory rate) and body temperature. ; At screening and at the end of each study period an additional blood sample will be taken for haematology, biochemistry and serological assessments (only in screening). ; Adverse events will continue to be assessed up to 7 days after the last dose of the study medication by spontaneous reporting and at a final follow‐up phone call. ; [Safety will be evaluated during each study period, and for 7 days following study drug administration. ] INCLUSION CRITERIA: Male or female subjects aged between 18 and 50 years, inclusive, on the day of consent. Voluntarily provide written informed consent before the initiation of any study‐related procedures. Have a Body Mass Index (BMI) between 18.5 and 30.0 kg/m2. Have no significant disease (asthma, peptic or gastric ulcer, sinusitis, pharyngitis, gastrointestinal disease, pulmonary disease, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, infective, dermatologic or immunological disorders) as determined by medical history, physical examination and laboratory tests. Have negative HIV and hepatitis B & C test results. Be able and willing to abstain from caffeine‐containing beverages (e.g. coffee, soda, energy drinks or tea), caffeine‐containing food (e.g. chocolate), and alcohol for at least 24 hours prior to stud