None listed
Conditions
Interventions
Intervention1: Iron Variant T1: One tablet containing ferric pyrophosphate equivalent to 27 mg elemental iron administered orally as a single dose.
Intervention2: Iron Variant T2: One mL liquid formul
Sponsors
Taiyo Kagaku India Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female human participants aged between 18 to 45 years (both inclusive). 2. Participants with a body mass index (BMI) between 18.50-30.00 kg/m2 and body mass, not less than 50.00 kg. 3. Female participant must have a negative urine pregnancy test prior to the housing. 4. Females of childbearing potential agreeing to use appropriate contraceptive measures like non hormonal intrauterine device, barrier methods, spermicidal agents during the study and 07 days after completion of the study. 5. Male agreeing to use appropriate contraceptive measures like the Double Barrier method (Condom), and should not donate sperm, etc. during the study and 07 days after completion of the study. 6. Participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests). 7. Participants having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording. 8. A negative alcohol breath test result. 9. Participant able to communicate effectively and provide written informed consent. 10. Participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee. 11. Participants that can provide adequate evidence of their identity. 12. Availability of volunteers for the entire study duration. 13. Ability to fast for at least 14.00 hours and consume standard meals. 14. Participants with normal hemoglobin levels as follows: Males:14 to 16 g/dl (both inclusive); Females: 12 to 14 g/dl (both inclusive).
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to iron or their salts or related product or any component of this intervention. 2. Incapable of understanding the informed consent information. 3. Clinically significant medical condition, such as, but not limited to, cardiovascular, neurological, psychiatric, pulmonary, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease), or uncontrolled haematological abnormalities. 4. Any treatment which could bring about induction or inhibition of the hepatic microsomal enzyme system within one month of starting the study. 5. History or presence of alcoholism or drug abuse. 6. History or presence of asthma, urticaria, or other allergic reactions. 7. History or presence of gastric and/or duodenal ulceration. 8. History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion. 9. History or presence of cancer. 10. Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week before study initiation and throughout the study. 11. Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study. 12. Smokers who smoke 9 or more cigarettes/day or inability to abstain during the study. 13. Participant consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours before initiation of the study and throughout the study. 14. Major illness during the 90 days before screening. 15. Participation in a drug research study within 90 days of screening. 16. Donation of blood within 90 days of screening. 17. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL. 18. History or presence of easy bruising or bleeding. 19. Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study. 20. Females of childbearing potential with any one of the following reported and documented on the medical history: i. Postmenopausal with spontaneous amenorrhea for at least one year, 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. iv. Female volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing. 21. Pregnant women and nursing mothers. 22. Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum pharmacokinetic (PK) parameters: F (relative bioavailability); Cmax, Tmax, AUC0-t, AUC0-infinity, t1/2, and Kel from the concentration Vs. time data and will be compared between groups. Timepoint: PK blood samples will be collected at pre-dose [within 45 min before IP administration] and post-dose at 1, 2, 4, 6, 8, 12 and 24h, | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. vital signs & clinical examinations 2. ECG 3. Clinical laboratory testing [hematology (CBC), lipid profile, random blood sugar (RBS), renal function test (RFT), liver function test (LFT). 4. Adverse events, serious adverse events. 5. Tolerability of the investigational productTimepoint: From Screening to end of the study | — |
Countries
India
Contacts
Public ContactMr T Akilesh Sai
Taiyo Kagaku India Pvt. Ltd.
Outcome results
None listed