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Clinical trial

An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Four Period, Full-replicate, Oral Bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of Ç.O.S.B., Karaağaç Mahallesi Fatih, Bulvarı No:32, Kapaklı/TEKİRDAĞ and Entresto® (Sacubitril and Valsartan) 97 mg/103 mg Tablets of Novartis Europharm Limited, Irija in Healthy, Adult, Human Subjects Under Fasting Condition.

NCT06922253 is registered in ClinicalTrials.gov with Humanis Saglık Anonim Sirketi as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Four Period, Full-replicate, Oral Bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of Ç.O.S.B., Karaağaç Mahallesi Fatih, Bulvarı No:32, Kapaklı/TEKİRDAĞ and Entresto® (Sacubitril and Valsartan) 97 mg/103 mg Tablets of Novartis Europharm Limited, Irija in Healthy, Adult, Human Subjects Under Fasting Condition.
Lead sponsor
Humanis Saglık Anonim Sirketi
Phase
Phase 1
Overall status
Completed
Start date
December 28, 2024
Completion date
March 17, 2025
Enrollment
48 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

chronic heart failure